AIDS-related Kaposi Sarcoma, AIDS Related Lymphoma, AIDS-Related Malignancy, Anal Cancer, Cancer, HIV-Associated Malignant Neoplasm, HIV Infections, HPV-Related Malignancy
Conditions
Keywords
HIV-Related Cancer, AIDS, AIDS-related malignancy, anal cancer, lymphoma, kaposi sarcoma, cervical cancer
Brief summary
This study is being done to understand how many people with HIV (PWH) present for cancer care across the AIDS Malignancy Consortium in the United States and if there are reasons that some PWH choose to participate, or not in cancer clinical trials. Optional quality of life surveys will be used to learn more about how HIV and cancer and HIV and cancer treatment affect people.
Detailed description
Primary Objective: To estimate the number of cancers in people with HIV (PWH) who present for care at domestic AMC sites Secondary Objectives: To characterize participants that are eligible but not enrolled onto AMC clinical trials to understand site-specific and trial-specific accrual barriers Exploratory Objectives: 1. To standardize and expand the quantity and quality of sociodemographic and cancer diagnostic and treatment characteristics collected for PWH receiving care at domestic AMC sites. 2. To describe cancer patient health-related QOL for PWH at domestic AMC sites using validated tools: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire \[EORTC QLQ-C30\] and Supportive Care Needs Survey Short Form 34 \[SCNS-SF34\] Outline: Participants identified via screening of electronic medical records or institutional databases. All eligible participants attend one visit for the collection of broad demographic and clinical data. Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit. Data collection at study visits will occur via survey procedures and/or medical record review.
Interventions
OTHERNon-Interventional
Participants will be identified via screening of electronic medical records or institutional databases. All eligible participants will have one visit for the collection of broad demographic and clinical data. Data collection at study visit will occur via survey procedures and/or medical record review.
OTHERNon-Interventional Follow-up
Participants initiating or receiving ongoing treatment for their cancer will attend a single follow-up visit to recollect broad demographic and clinical data. Data collection at study visits will occur via survey procedures and/or medical record review.
Sponsors
AIDS Malignancy Consortium
National Cancer Institute (NCI)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant can understand and is willing to sign a written informed consent document. * HIV positive. Documentation of HIV-1 infection by means of any one of the following: * Documentation of an HIV diagnosis in the medical record by a licensed health care provider; * Documentation of receipt of antiretroviral therapy (ART) (i.e., at least two different medications that do not constitute a prescription for pre-exposure prophylaxis \[PrEP\]) by a licensed health care provider. Documentation may be a record of an ART prescription in the medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name; * HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating \>1000 RNA copies/mL; * Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay. Note: The term "licensed" refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally (e.g., U.S. FDA). WHO (World Health Organization) and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay, or an E/CIA that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), a Western blot, or a plasma HIV-1 RNA viral load. * Patient was diagnosed with or treated for cancer within the last 5 years. Participants will qualify under one of three categories: * New, primary or recurrent diagnosis -Considering or currently receiving cancer treatment * Metastatic or locally advanced cancer - This includes cases for which there are no current definitive therapy options for cure (i.e., inoperable) but may be considered for non-standard / non-curative therapies. * Prior diagnosis (within 5 years), in remission - Not currently on cancer treatment other than ART or maintenance therapy. * Age ≥ 18 years. * Participant presents to an AMC domestic clinical trial site for either clinical care or research.
Exclusion criteria
* Participants who do not fulfill the criteria as listed above are ineligible.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Cancers in People With HIV (PWH) Who Present for Care at Domestic AMC Sites | Enrollment | For each cancer group listed below, the number of new and existing cases per month will be estimated. The distribution of cancer types will be computed as percentages and compared to the cancer type distribution in the HIV/AIDS Cancer Match (HACM) Study: 1. Solid organ tumors associated with human papillomavirus (HPV) infection 2. Solid organ tumors unrelated to HPV 3. Kaposi sarcoma 4. Hematologic malignancies |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Eligible for AMC Trials Who Are Successfully Enrolled | Baseline | This will be calculated by the number of participants enrolled who meet site-based AMC trial eligibility compared to the number of eligible participants at each site who meet site-based AMC trial eligibility. |
Countries
Puerto Rico, United States
Contacts
STUDY_CHAIRAnna E Coghill, PhD, MPH
AIDS Malignancy Consortium
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 57 years |
| Education College degree or equivalent | 77 Participants |
| Education High school graduate or below | 57 Participants |
| Education Never attended school | 3 Participants |
| Education Unknown/not reported | 210 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 111 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 335 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 14 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 179 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 26 Participants |
| Race (NIH/OMB) White | 125 Participants |
| Sex/Gender, Customized Female | 71 Participants |
| Sex/Gender, Customized Male | 221 Participants |
| Sex/Gender, Customized Not reported/Unknown | 1 Participants |
| Sex/Gender, Customized Transgender | 2 Participants |
| Smoking history Current use | 95 Participants |
| Smoking history Never used | 12 Participants |
| Smoking history Quit/former use | 179 Participants |
| Smoking history Unknown | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
None listed