Cancer
Conditions
Keywords
viral screening
Brief summary
The goal of this study is to estimate the prevalence of HIV, Hepatitis B and hepatitis C infection among newly diagnosed cancer patients presenting to community and academic oncology clinics.
Detailed description
Primary Objective Among newly diagnosed cancer patients presenting to SWOG-affiliated community and academic oncology clinics, estimate the prevalence of human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection. Prevalence estimates will be further stratified: by whether infection with the virus(es) is known, as reported by patients and/or their physician prior to study testing, vs. unknown; by presenting cancer type, and by self-reported risk factors for each virus. Secondary Objectives * Evaluate known sociodemographic, clinical, and behavioral factors that are significantly associated with previously undiagnosed HIV, HBV, and/or HCV infection in a population of people with newly diagnosed cancer. * Among patients who are identified as having HIV, HBV, and/or HCV, evaluate the timing and type of treatments received, both for the viral infections and the cancers. * Evaluate type and rate of cancer treatment-related adverse events in patients with HIV, HBV, and/or HCV infection. * Using simulation modeling that is directly informed by the data obtained from this study, determine the cost-effectiveness (expressed as cost per infection detected and cost per year of life gained) of (1) routine, universal screening and (2) risk factor-directed screening of newly diagnosed cancer patients for HIV, HBV, and/or HCV vs. current care. Tertiary Objective Create a biorepository of stored serum for future translational medicine studies that may include identifying genomic and viral factors that increase the risk of serious adverse effects among participants infected with HIV, HBV, and/or HCV being treated for invasive cancers.
Interventions
None listed
Sponsors
National Cancer Institute (NCI)
SWOG Cancer Research Network
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* presenting for evaluation or treatment of a new cancer malignancy(including hematologic) * confirmed pathologic diagnosis must be within 120 days of registration (Patients presenting for second opinions of confirmed malignancies are eligible, including those who have started cancer treatment at other facilities) * at least 18 years of age * patient must have had their blood drawn for HIV, HBV and HCV testing prior to registration (Patients who have had HIV, HBV and/or HCV testing within 60 days prior to registration and who do not wish to be retested are eligible, provided supporting documents can be obtained confirming viral test results for all three viruses. Documentation must be obtained prior to registration. Patients who are viral positive for either HIV, HBV, and/or HCV and who do not wish to be retested are eligible, provided documentation of viral load within 120 days prior to registration can be obtained. Note that these patients must be tested for or provide current viral load for all three viruses to be eligible. Documentation must be obtained prior to registration.) * Patients must sign and give written informed consent in accordance with institutional and federal guidelines * Patients must be offered the opportunity to allow their blood specimens to be banked by the SWOG Repository for future research
Exclusion criteria
* diagnosed with a malignancy other than the current malignancy within the past five years (with the exception of basal cell or squamous cell skin cancer, in situ cervical cancer, or in situ breast cancer.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Positive Viral Infection | Up to 21 days after registration | An estimate of the prevalence of human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection among newly diagnosed cancer participants presenting to SWOG-affiliated community and academic oncology clinics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Important Risk Factors in Participants Tested for Chronic HBV | Up to 21 days after registration | The presence or absence of specific risk factors among participants evaluated for chronic HBV is evaluated. |
| Presence of Important Risk Factors in Participants Tested for HCV | Up to 21 days after registration | The presence or absence of specific risk factors among participants evaluated for HCV is evaluated. |
| Presence of Important Risk Factors in Participants Tested for HIV | Up to 21 days after registration | The presence or absence of specific risk factors among participants evaluated for HIV is evaluated. |
| Presence of Important Risk Factors in Participants Tested for Previous HBV | Up to 21 days after registration | The presence or absence of specific risk factors among participants evaluated for previous HBV is evaluated. |
| Type and Rate of Adverse Events Among Patients With Viral Infection. | 5 years after registration | Estimate type and rate of cancer-treatment related adverse events among persons with HIV, HBV, and/or HCV infection. |
| Cost-effectiveness of Viral Screening | 3 years after registration | Estimate the cost-effectiveness of screening for HIV, HBV, and HCV. |
| Type of Treatment for Cancer and Virus in Participants With Positive Viral Test | 60 days after registration | Among participants with HIV, HBV, or HCV, the timing and type of treatments received, both for the viral infections and the cancers that were evaluated. |
Countries
United States
Participant flow
Pre-assignment details
3092 participants were screened for the trial; 41 were deemed ineligible and 3051 eligible participants were registered to the trial.
Participants by arm
| Arm | Count |
|---|---|
| Participants With Newly Diagnosed Cancer Participants with newly diagnosed cancer that underwent viral testing for at least one of the following: HBV, HCV, and HIV. | 3,051 |
| Total | 3,051 |
Baseline characteristics
| Characteristic | Participants With Newly Diagnosed Cancer |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1084 Participants |
| Age, Categorical Between 18 and 65 years | 1967 Participants |
| Age, Continuous | 60.6 years |
| Cancer Type Blood or marrow | 369 Participants |
| Cancer Type Breast | 1058 Participants |
| Cancer Type Gastrointestinal, liver | 62 Participants |
| Cancer Type Gastrointestinal, other | 235 Participants |
| Cancer Type Gastrointestinal tract, colorectal | 362 Participants |
| Cancer Type Head and neck | 112 Participants |
| Cancer Type Lung | 356 Participants |
| Cancer Type Missing | 5 Participants |
| Cancer Type Other | 392 Participants |
| Cancer Type Prostate | 100 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 558 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2478 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 15 Participants |
| Race/Ethnicity, Customized Race Asian | 102 Participants |
| Race/Ethnicity, Customized Race Black | 553 Participants |
| Race/Ethnicity, Customized Race Other | 115 Participants |
| Race/Ethnicity, Customized Race White | 2281 Participants |
| Region South and Northeast United States | 1955 Participants |
| Region West and Midwest United States | 1096 Participants |
| Sex: Female, Male Female | 1842 Participants |
| Sex: Female, Male Male | 1209 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 3,051 |
| other Total, other adverse events | 0 / 3,051 |
| serious Total, serious adverse events | 0 / 3,051 |
Outcome results
Primary
Number of Participants With Positive Viral Infection
An estimate of the prevalence of human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection among newly diagnosed cancer participants presenting to SWOG-affiliated community and academic oncology clinics.
Time frame: Up to 21 days after registration
Population: The analysis population includes the 3051 participants eligible to receive at least one viral test (for HBV, HCV, or HIV). 3050 participants were evaluable for HBV analysis (1 participants had no HBV test results available), 2990 participants were evaluable for HCV analysis (5 participants had no HCV test results available and 56 participants incomplete test results), and 3045 participants were evaluable for HIV analysis (6 participants had no HIV test results available).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Evaluated for Chronic HBV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Lung Cancer | 2 Participants |
| Evaluated for Chronic HBV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Other Cancer | 1 Participants |
| Evaluated for Chronic HBV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with GI, Other Tract Cancer | 3 Participants |
| Evaluated for Chronic HBV | Number of Participants With Positive Viral Infection | Positive Viral Test in All Participants | 19 Participants |
| Evaluated for Chronic HBV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Head and Neck Cancer | 1 Participants |
| Evaluated for Chronic HBV | Number of Participants With Positive Viral Infection | Positive Viral Test in Newly Diagnosed Participants | 8 Participants |
| Evaluated for Chronic HBV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Blood/Marrow Cancer | 2 Participants |
| Evaluated for Chronic HBV | Number of Participants With Positive Viral Infection | Positive Viral Test in Previously Diagnosed Participants | 11 Participants |
| Evaluated for Chronic HBV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Prostate Cancer | 0 Participants |
| Evaluated for Chronic HBV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Breast Cancer | 4 Participants |
| Evaluated for Chronic HBV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Colorectal Cancer | 2 Participants |
| Evaluated for Chronic HBV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Liver Cancer | 4 Participants |
| Evaluated for Previous HBV | Number of Participants With Positive Viral Infection | Positive Viral Test in Previously Diagnosed Participants | 25 Participants |
| Evaluated for Previous HBV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Liver Cancer | 5 Participants |
| Evaluated for Previous HBV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Blood/Marrow Cancer | 16 Participants |
| Evaluated for Previous HBV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Head and Neck Cancer | 9 Participants |
| Evaluated for Previous HBV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Lung Cancer | 31 Participants |
| Evaluated for Previous HBV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with GI, Other Tract Cancer | 22 Participants |
| Evaluated for Previous HBV | Number of Participants With Positive Viral Infection | Positive Viral Test in All Participants | 197 Participants |
| Evaluated for Previous HBV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Colorectal Cancer | 18 Participants |
| Evaluated for Previous HBV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Breast Cancer | 66 Participants |
| Evaluated for Previous HBV | Number of Participants With Positive Viral Infection | Positive Viral Test in Newly Diagnosed Participants | 172 Participants |
| Evaluated for Previous HBV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Other Cancer | 18 Participants |
| Evaluated for Previous HBV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Prostate Cancer | 12 Participants |
| Evaluated for HCV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with GI, Other Tract Cancer | 3 Participants |
| Evaluated for HCV | Number of Participants With Positive Viral Infection | Positive Viral Test in All Participants | 71 Participants |
| Evaluated for HCV | Number of Participants With Positive Viral Infection | Positive Viral Test in Previously Diagnosed Participants | 49 Participants |
| Evaluated for HCV | Number of Participants With Positive Viral Infection | Positive Viral Test in Newly Diagnosed Participants | 22 Participants |
| Evaluated for HCV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Blood/Marrow Cancer | 9 Participants |
| Evaluated for HCV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Breast Cancer | 9 Participants |
| Evaluated for HCV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Colorectal Cancer | 7 Participants |
| Evaluated for HCV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Liver Cancer | 9 Participants |
| Evaluated for HCV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Head and Neck Cancer | 5 Participants |
| Evaluated for HCV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Lung Cancer | 17 Participants |
| Evaluated for HCV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Prostate Cancer | 3 Participants |
| Evaluated for HCV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Other Cancer | 9 Participants |
| Evaluated for HIV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Colorectal Cancer | 5 Participants |
| Evaluated for HIV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Breast Cancer | 2 Participants |
| Evaluated for HIV | Number of Participants With Positive Viral Infection | Positive Viral Test in All Participants | 34 Participants |
| Evaluated for HIV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Lung Cancer | 4 Participants |
| Evaluated for HIV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Blood/Marrow Cancer | 7 Participants |
| Evaluated for HIV | Number of Participants With Positive Viral Infection | Positive Viral Test in Newly Diagnosed Participants | 2 Participants |
| Evaluated for HIV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Other Cancer | 9 Participants |
| Evaluated for HIV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Prostate Cancer | 1 Participants |
| Evaluated for HIV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with GI, Other Tract Cancer | 5 Participants |
| Evaluated for HIV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Liver Cancer | 0 Participants |
| Evaluated for HIV | Number of Participants With Positive Viral Infection | Positive Viral Test in Previously Diagnosed Participants | 32 Participants |
| Evaluated for HIV | Number of Participants With Positive Viral Infection | Positive Viral Test in Participants with Head and Neck Cancer | 1 Participants |
Secondary
Cost-effectiveness of Viral Screening
Estimate the cost-effectiveness of screening for HIV, HBV, and HCV.
Time frame: 3 years after registration
Secondary
Presence of Important Risk Factors in Participants Tested for Chronic HBV
The presence or absence of specific risk factors among participants evaluated for chronic HBV is evaluated.
Time frame: Up to 21 days after registration
Population: The analysis population includes the 2940 of the 3050 participants who were evaluable for HBV analysis and completed the risk factor survey.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Born in high HBV prevalence region | Risk Factor Present | 8 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Born in high HBV prevalence region | Risk Factor Absent | 10 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Needle-stick exposure | Risk Factor Present | 3 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Needle-stick exposure | Risk Factor Absent | 15 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Unprotected sex with MSM, multiple, or anonymous partners | Risk Factor Present | 2 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Unprotected sex with MSM, multiple, or anonymous partners | Risk Factor Absent | 16 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Unprotected sex with high-risk person | Risk Factor Present | 2 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Unprotected sex with high-risk person | Risk Factor Absent | 16 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Sexual contact with hepatitis-positive person | Risk Factor Present | 1 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Sexual contact with hepatitis-positive person | Risk Factor Absent | 17 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Diagnosis or treatment for STD | Risk Factor Present | 4 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Diagnosis or treatment for STD | Risk Factor Absent | 14 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Self-reported infection with HCV or HIV | Risk Factor Present | 2 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Self-reported infection with HCV or HIV | Risk Factor Absent | 16 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Household contact with hepatitis-positive person | Risk Factor Present | 1 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Household contact with hepatitis-positive person | Risk Factor Absent | 17 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Household contact with hepatitis-positive person | Risk Factor Absent | 2737 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Born in high HBV prevalence region | Risk Factor Present | 298 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Sexual contact with hepatitis-positive person | Risk Factor Present | 65 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Born in high HBV prevalence region | Risk Factor Absent | 2624 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Self-reported infection with HCV or HIV | Risk Factor Present | 174 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Needle-stick exposure | Risk Factor Present | 145 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Sexual contact with hepatitis-positive person | Risk Factor Absent | 2857 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Needle-stick exposure | Risk Factor Absent | 2777 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Household contact with hepatitis-positive person | Risk Factor Present | 185 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Unprotected sex with MSM, multiple, or anonymous partners | Risk Factor Present | 115 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Diagnosis or treatment for STD | Risk Factor Present | 304 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Unprotected sex with MSM, multiple, or anonymous partners | Risk Factor Absent | 2807 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Self-reported infection with HCV or HIV | Risk Factor Absent | 2748 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Unprotected sex with high-risk person | Risk Factor Present | 128 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Diagnosis or treatment for STD | Risk Factor Absent | 2618 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Chronic HBV | Unprotected sex with high-risk person | Risk Factor Absent | 2794 Participants |
Secondary
Presence of Important Risk Factors in Participants Tested for HCV
The presence or absence of specific risk factors among participants evaluated for HCV is evaluated.
Time frame: Up to 21 days after registration
Population: The analysis population includes the 2882 of the 2990 participants who were evaluable for HCV analysis completed the risk factor survey.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HCV | Injected drug use | Risk Factor Present | 21 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HCV | Injected drug use | Risk Factor Absent | 48 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HCV | Tested because of blood exposure, injected drug use, or transfusion before 1992 | Risk Factor Present | 9 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HCV | Tested because of blood exposure, injected drug use, or transfusion before 1992 | Risk Factor Absent | 60 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HCV | Tested because of symptoms | Risk Factor Present | 7 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HCV | Tested because of symptoms | Risk Factor Absent | 62 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HCV | Blood transfusion between 1978-1985 | Risk Factor Present | 11 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HCV | Blood transfusion between 1978-1985 | Risk Factor Absent | 58 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HCV | Tested because born between 1945-1965 | Risk Factor Present | 11 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HCV | Tested because born between 1945-1965 | Risk Factor Absent | 58 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HCV | Self-reported infection with HIV | Risk Factor Present | 4 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HCV | Self-reported infection with HIV | Risk Factor Absent | 65 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HCV | Snorted cocaine | Risk Factor Present | 15 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HCV | Snorted cocaine | Risk Factor Absent | 54 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HCV | Needle-stick exposure | Risk Factor Present | 7 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HCV | Needle-stick exposure | Risk Factor Absent | 62 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HCV | High-risk occupation | Risk Factor Present | 3 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HCV | High-risk occupation | Risk Factor Absent | 66 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HCV | Snorted cocaine | Risk Factor Absent | 2559 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HCV | Injected drug use | Risk Factor Present | 67 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HCV | Tested because born between 1945-1965 | Risk Factor Absent | 2687 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HCV | Injected drug use | Risk Factor Absent | 2746 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HCV | High-risk occupation | Risk Factor Absent | 2618 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HCV | Tested because of blood exposure, injected drug use, or transfusion before 1992 | Risk Factor Present | 45 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HCV | Self-reported infection with HIV | Risk Factor Present | 48 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HCV | Tested because of blood exposure, injected drug use, or transfusion before 1992 | Risk Factor Absent | 2768 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HCV | Needle-stick exposure | Risk Factor Present | 134 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HCV | Tested because of symptoms | Risk Factor Present | 46 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HCV | Self-reported infection with HIV | Risk Factor Absent | 2765 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HCV | Tested because of symptoms | Risk Factor Absent | 2767 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HCV | High-risk occupation | Risk Factor Present | 195 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HCV | Blood transfusion between 1978-1985 | Risk Factor Present | 104 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HCV | Snorted cocaine | Risk Factor Present | 254 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HCV | Blood transfusion between 1978-1985 | Risk Factor Absent | 2709 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HCV | Needle-stick exposure | Risk Factor Absent | 2679 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HCV | Tested because born between 1945-1965 | Risk Factor Present | 126 Participants |
Secondary
Presence of Important Risk Factors in Participants Tested for HIV
The presence or absence of specific risk factors among participants evaluated for HIV is evaluated.
Time frame: Up to 21 days after registration
Population: The analysis population includes the 2934 of the 3045 participants were evaluable for HIV analysis and completed the risk factor survey.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HIV | Diagnosis or treatment for STD | Risk Factor Present | 20 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HIV | Self-reported infection with HBV | Risk Factor Absent | 30 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HIV | Unprotected sex with MSM, multiple, or anonymous partners | Risk Factor Present | 16 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HIV | Diagnosis or treatment for tuberculosis | Risk Factor Present | 5 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HIV | Diagnosis or treatment for STD | Risk Factor Absent | 14 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HIV | Diagnosis or treatment for tuberculosis | Risk Factor Absent | 29 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HIV | Sexual contact with HIV-positive person | Risk Factor Absent | 18 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HIV | Injected drug use | Risk Factor Present | 3 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HIV | Unprotected sex with high-risk person | Risk Factor Present | 12 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HIV | Injected drug use | Risk Factor Absent | 31 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HIV | Unprotected sex with MSM, multiple, or anonymous partners | Risk Factor Absent | 18 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HIV | Needle-stick exposure | Risk Factor Present | 1 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HIV | Unprotected sex with high-risk person | Risk Factor Absent | 22 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HIV | Needle-stick exposure | Risk Factor Absent | 33 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HIV | Sexual contact with HIV-positive person | Risk Factor Present | 16 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HIV | High-risk occupation | Risk Factor Present | 1 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HIV | Self-reported infection with HBV | Risk Factor Present | 4 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for HIV | High-risk occupation | Risk Factor Absent | 33 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HIV | High-risk occupation | Risk Factor Absent | 2701 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HIV | Sexual contact with HIV-positive person | Risk Factor Present | 23 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HIV | Sexual contact with HIV-positive person | Risk Factor Absent | 2877 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HIV | Unprotected sex with MSM, multiple, or anonymous partners | Risk Factor Present | 101 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HIV | Unprotected sex with MSM, multiple, or anonymous partners | Risk Factor Absent | 2799 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HIV | Diagnosis or treatment for STD | Risk Factor Present | 288 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HIV | Diagnosis or treatment for STD | Risk Factor Absent | 2612 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HIV | Unprotected sex with high-risk person | Risk Factor Present | 118 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HIV | Unprotected sex with high-risk person | Risk Factor Absent | 2782 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HIV | Self-reported infection with HBV | Risk Factor Present | 51 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HIV | Self-reported infection with HBV | Risk Factor Absent | 2849 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HIV | Diagnosis or treatment for tuberculosis | Risk Factor Present | 92 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HIV | Diagnosis or treatment for tuberculosis | Risk Factor Absent | 2808 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HIV | Injected drug use | Risk Factor Present | 104 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HIV | Injected drug use | Risk Factor Absent | 2796 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HIV | Needle-stick exposure | Risk Factor Present | 147 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HIV | Needle-stick exposure | Risk Factor Absent | 2753 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for HIV | High-risk occupation | Risk Factor Present | 199 Participants |
Secondary
Presence of Important Risk Factors in Participants Tested for Previous HBV
The presence or absence of specific risk factors among participants evaluated for previous HBV is evaluated.
Time frame: Up to 21 days after registration
Population: The analysis population includes the 2940 of the 3050 participants who were evaluable for HBV analysis and completed the risk factor survey.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Injected drug use | Risk Factor Present | 21 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Sexual contact with HIV-positive person | Risk Factor Absent | 176 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Self-reported infection with HCV or HIV | Risk Factor Present | 41 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Self-reported infection with HCV or HIV | Risk Factor Absent | 149 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Born in high HBV prevalence region | Risk Factor Present | 63 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Born in high HBV prevalence region | Risk Factor Absent | 127 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Sexual contact with HIV-positive person | Risk Factor Present | 14 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Injected drug use | Risk Factor Absent | 169 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Unprotected sex with high-risk person | Risk Factor Present | 21 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Unprotected sex with high-risk person | Risk Factor Absent | 169 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Sexual contact with hepatitis-positive person | Risk Factor Present | 10 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Sexual contact with hepatitis-positive person | Risk Factor Absent | 180 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Unprotected sex with MSM, multiple, or anonymous partners | Risk Factor Present | 14 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Unprotected sex with MSM, multiple, or anonymous partners | Risk Factor Absent | 176 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Diagnosis or treatment for STD | Risk Factor Present | 32 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Diagnosis or treatment for STD | Risk Factor Absent | 158 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Blood transfusion between 1978-1985 | Risk Factor Present | 13 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Blood transfusion between 1978-1985 | Risk Factor Absent | 177 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Needle-stick exposure | Risk Factor Present | 12 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Needle-stick exposure | Risk Factor Absent | 178 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Household contact with hepatitis-positive person | Risk Factor Present | 15 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Household contact with hepatitis-positive person | Risk Factor Absent | 175 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | High-risk occupation | Risk Factor Present | 11 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | High-risk occupation | Risk Factor Absent | 179 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Completed HBV vaccine (3 or more doses) | Risk Factor Present | 8 Participants |
| Evaluated for Chronic HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Completed HBV vaccine (3 or more doses) | Risk Factor Absent | 182 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Needle-stick exposure | Risk Factor Absent | 2614 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Sexual contact with HIV-positive person | Risk Factor Present | 25 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Unprotected sex with MSM, multiple, or anonymous partners | Risk Factor Absent | 2647 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Sexual contact with HIV-positive person | Risk Factor Absent | 2725 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Completed HBV vaccine (3 or more doses) | Risk Factor Present | 236 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Self-reported infection with HCV or HIV | Risk Factor Present | 135 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Diagnosis or treatment for STD | Risk Factor Present | 276 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Self-reported infection with HCV or HIV | Risk Factor Absent | 2615 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Household contact with hepatitis-positive person | Risk Factor Present | 171 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Born in high HBV prevalence region | Risk Factor Present | 243 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Diagnosis or treatment for STD | Risk Factor Absent | 2474 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Born in high HBV prevalence region | Risk Factor Absent | 2507 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | High-risk occupation | Risk Factor Absent | 2560 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Injected drug use | Risk Factor Present | 86 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Blood transfusion between 1978-1985 | Risk Factor Present | 110 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Injected drug use | Risk Factor Absent | 2664 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Household contact with hepatitis-positive person | Risk Factor Absent | 2579 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Unprotected sex with high-risk person | Risk Factor Present | 109 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Blood transfusion between 1978-1985 | Risk Factor Absent | 2640 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Unprotected sex with high-risk person | Risk Factor Absent | 2641 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Completed HBV vaccine (3 or more doses) | Risk Factor Absent | 2514 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Sexual contact with hepatitis-positive person | Risk Factor Present | 56 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Needle-stick exposure | Risk Factor Present | 136 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Sexual contact with hepatitis-positive person | Risk Factor Absent | 2694 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | High-risk occupation | Risk Factor Present | 190 Participants |
| Evaluated for Previous HBV | Presence of Important Risk Factors in Participants Tested for Previous HBV | Unprotected sex with MSM, multiple, or anonymous partners | Risk Factor Present | 103 Participants |
Secondary
Type and Rate of Adverse Events Among Patients With Viral Infection.
Estimate type and rate of cancer-treatment related adverse events among persons with HIV, HBV, and/or HCV infection.
Time frame: 5 years after registration
Secondary
Type of Treatment for Cancer and Virus in Participants With Positive Viral Test
Among participants with HIV, HBV, or HCV, the timing and type of treatments received, both for the viral infections and the cancers that were evaluated.
Time frame: 60 days after registration
Population: The analysis population includes the 224 participants who were viral positive for at least one viral test (for HBV, HCV, or HIV) and had treatment outcome data available. Of the 292 patients were who were viral positive for at least one viral test, 11 patients did not have data submitted and 57 patients did not have data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Evaluated for Chronic HBV | Type of Treatment for Cancer and Virus in Participants With Positive Viral Test | Received Antiviral or Antiretroviral Drugs | 11.8 percentage of participants |
| Evaluated for Chronic HBV | Type of Treatment for Cancer and Virus in Participants With Positive Viral Test | Change in Cancer Treatment | 59.2 percentage of participants |
| Evaluated for Chronic HBV | Type of Treatment for Cancer and Virus in Participants With Positive Viral Test | Change in Cancer Treatment due to Viral Positive Status | 7.9 percentage of participants |
| Evaluated for Chronic HBV | Type of Treatment for Cancer and Virus in Participants With Positive Viral Test | Change in Cancer Treatment due to Viral Positive Status and Added Antiviral or Antiretroviral Drugs | 5.3 percentage of participants |
| Evaluated for Previous HBV | Type of Treatment for Cancer and Virus in Participants With Positive Viral Test | Received Antiviral or Antiretroviral Drugs | 73.3 percentage of participants |
| Evaluated for Previous HBV | Type of Treatment for Cancer and Virus in Participants With Positive Viral Test | Change in Cancer Treatment due to Viral Positive Status and Added Antiviral or Antiretroviral Drugs | 13.3 percentage of participants |
| Evaluated for Previous HBV | Type of Treatment for Cancer and Virus in Participants With Positive Viral Test | Change in Cancer Treatment | 53.3 percentage of participants |
| Evaluated for Previous HBV | Type of Treatment for Cancer and Virus in Participants With Positive Viral Test | Change in Cancer Treatment due to Viral Positive Status | 13.3 percentage of participants |
| Evaluated for HCV | Type of Treatment for Cancer and Virus in Participants With Positive Viral Test | Change in Cancer Treatment due to Viral Positive Status and Added Antiviral or Antiretroviral Drugs | 2 percentage of participants |
| Evaluated for HCV | Type of Treatment for Cancer and Virus in Participants With Positive Viral Test | Change in Cancer Treatment | 55.1 percentage of participants |
| Evaluated for HCV | Type of Treatment for Cancer and Virus in Participants With Positive Viral Test | Change in Cancer Treatment due to Viral Positive Status | 6.1 percentage of participants |
| Evaluated for HCV | Type of Treatment for Cancer and Virus in Participants With Positive Viral Test | Received Antiviral or Antiretroviral Drugs | 8.2 percentage of participants |
| Evaluated for HIV | Type of Treatment for Cancer and Virus in Participants With Positive Viral Test | Received Antiviral or Antiretroviral Drugs | 66.7 percentage of participants |
| Evaluated for HIV | Type of Treatment for Cancer and Virus in Participants With Positive Viral Test | Change in Cancer Treatment | 50 percentage of participants |
| Evaluated for HIV | Type of Treatment for Cancer and Virus in Participants With Positive Viral Test | Change in Cancer Treatment due to Viral Positive Status and Added Antiviral or Antiretroviral Drugs | 13.3 percentage of participants |
| Evaluated for HIV | Type of Treatment for Cancer and Virus in Participants With Positive Viral Test | Change in Cancer Treatment due to Viral Positive Status | 16.7 percentage of participants |
| Participants With Any Type Of Viral Infection | Type of Treatment for Cancer and Virus in Participants With Positive Viral Test | Change in Cancer Treatment due to Viral Positive Status and Added Antiviral or Antiretroviral Drugs | 6.3 percentage of participants |
| Participants With Any Type Of Viral Infection | Type of Treatment for Cancer and Virus in Participants With Positive Viral Test | Change in Cancer Treatment due to Viral Positive Status | 8 percentage of participants |
| Participants With Any Type Of Viral Infection | Type of Treatment for Cancer and Virus in Participants With Positive Viral Test | Change in Cancer Treatment | 58.5 percentage of participants |
| Participants With Any Type Of Viral Infection | Type of Treatment for Cancer and Virus in Participants With Positive Viral Test | Received Antiviral or Antiretroviral Drugs | 19.6 percentage of participants |