Breast Cancer, Hepatitis C
Conditions
Keywords
Breast cancer, Hepatitis C virus, Prognosis, Epidemiology
Brief summary
Hepatitis C viral infection is a major health problem in Egypt. The management of breast cancer patients is often complicated by the presence of associated HCV infection. This study aims at investigating the epidemiological association of the two conditions. It will also investigate the possible correlation with treatment outcome.
Detailed description
Breast cancer is the most common cancer in adult Egyptian females. The world's highest prevalence of hepatitis C virus is found in Egypt. Several investigators examined the epidemiological association of HCV with breast cancer. Published literature reports conflicting results regarding the HCV association with breast cancer incidence. Population-based studies from HCV-endemic area demonstrated increased breast cancer incidence in HCV-positive women younger than 50 years. On the other hand, population studies from HCV-low prevalence regions failed to detect an association of the virus with breast cancer. HCV seropositive patients constitute a large sector of oncology patients treated in Egyptian practice. HCV infection with or without clinically-significant liver disease impose several therapeutic, social and logistic problems. Recently, investigators from Mansoura University reported their findings among breast cancerpatients. According to these data, HCV-positive breast cancer patients had several markers of disease aggression such as large tumor size, high tumor grade and nodal infiltration. Moreover, HCV-NS4 (non-structural protein-4) blood levels positively correlated with the level of the known breast cancer marker CA15-3. In the current study, the investigators will investigate the incidence of HCV seropositivity in breast cancer patients and an age-matched control group. The study also examines the association of HCV status on the patients' baseline characteristics such as tumor stage and grade and with patients' treatment plan and treatment outcome. Specifically, the aims of the study are the following: 1. To test if HCV seropositivity is associated with breast cancer diagnosis in Egyptian population. 2. To test if HCV-positive patients harbour more aggressive breast tumors. 3. To test if HCV-positivity affects management decision in breast cancer patients. 4. To test if HCV-positive patients suffer more frequent adverse effects to breast cancer treatment. 5. To compare disease-free survival of HCV seropositive breast cancer patients vs. seronegative patients.
Interventions
None listed
Sponsors
Mansoura University
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Biopsy-proven invasive breast cancer.
Exclusion criteria
* Patients with unknown viral marker status. * Patients who did not complete their management at OCMU. * Patients with multiple cancer diagnoses. * Patients with virus-unrelated hepatic pathology.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of HCV Seropositivity in Breast Cancer Patients. | This outcome will be assessed through study completion, an average of 6 months. | Percentage of patients with breast cancer with positive anti-HCV serological test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease-related Events | at the date of last patients' visit recorded on her file. Patients should be censored at least 12 months from the time of diagnosis. | The number of events related to breast cancer diagnosis. Disease-free survival (DFS) was calculated as the time from the date of breast cancer diagnosis to the date of last follow-up or the date of first breast cancer-related event. At the time of analysis, median survival has not been reached. |
Countries
Egypt
Participant flow
Recruitment details
The Hospital medical record system was searched to identify patients with the malignant neoplasm of the breast diagnosis. The information of an un-selected sample of 650 patients was retrieved from the system. Two-hundred forty-five patients with incomplete data were excluded. The remaining 405 patients were subjected for further analysis.
Pre-assignment details
The study group was retrospectively extracted from hospital file. However, The Dakahlia Governorate adult female Population is a historical control group derived from the raw data of a previous study. As such, this control group has not been recruited in the current study.
Participants by arm
| Arm | Count |
|---|---|
| Study Group Randomly selected data of 405 patients treated within the last ten years at the study site. | 405 |
| Dakahlia Governorate Adult Female Population A historical control group derived from the raw data of a previously published study (PMID: 31463388, PMCID: PMC6709406, DOI: 10.1016/j.heliyon.2019.e02249) | 145 |
| Total | 550 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | incomplete data on file | 245 | 0 |
Baseline characteristics
| Characteristic | Study Group | Dakahlia Governorate Adult Female Population | Total |
|---|---|---|---|
| Age, Customized < 45 years | 127 Participants | 93 Participants | 220 Participants |
| Age, Customized 45 years or above | 278 Participants | 52 Participants | 330 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Egypt | 405 participants | 145 participants | 550 participants |
| Sex: Female, Male Female | 405 Participants | 145 Participants | 550 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Prevalence of HCV Seropositivity in Breast Cancer Patients.
Percentage of patients with breast cancer with positive anti-HCV serological test.
Time frame: This outcome will be assessed through study completion, an average of 6 months.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Study Group | Prevalence of HCV Seropositivity in Breast Cancer Patients. | anti-HCV Seropositive | 88 Participants |
| Study Group | Prevalence of HCV Seropositivity in Breast Cancer Patients. | anti-HCV seronegative | 317 Participants |
| Dakahlia Governorate Adult Female Population | Prevalence of HCV Seropositivity in Breast Cancer Patients. | anti-HCV Seropositive | 15 Participants |
| Dakahlia Governorate Adult Female Population | Prevalence of HCV Seropositivity in Breast Cancer Patients. | anti-HCV seronegative | 130 Participants |
Comparison: Fisher exact test was used for testing of association of Breast Cancer diagnosis with anti-HCV test status.p-value: 0.002795% CI: [1.341, 4.316]Fisher Exact
Comparison: Fisher exact test was used to test the association of Breast Cancer diagnosis with anti-HCV test result in women younger than 45 years.p-value: 0.003495% CI: [1.582, 31.25]Fisher Exact
Secondary
Disease-related Events
The number of events related to breast cancer diagnosis. Disease-free survival (DFS) was calculated as the time from the date of breast cancer diagnosis to the date of last follow-up or the date of first breast cancer-related event. At the time of analysis, median survival has not been reached.
Time frame: at the date of last patients' visit recorded on her file. Patients should be censored at least 12 months from the time of diagnosis.
Population: At the time of analysis, median survival has not been reached. This Outcome Measure was pre-specified to be collected only for the Study Group. The outcome is not applicable to the control group (non-cancer population).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Group | Disease-related Events | 37 number of events related to cancer |
| Dakahlia Governorate Adult Female Population | Disease-related Events | 6 number of events related to cancer |