Association of Hepatitis C Virus With Breast Cancer
|ClinicalTrials.gov Identifier: NCT04090164|
Recruitment Status : Active, not recruiting
First Posted : September 16, 2019
Last Update Posted : October 8, 2019
|Condition or disease|
|Breast Cancer Hepatitis C|
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:
- To test if HCV seropositivity is associated with breast cancer diagnosis in Egyptian population.
- To test if HCV-positive patients harbour more aggressive breast tumors.
- To test if HCV-positivity affects management decision in breast cancer patients.
- To test if HCV-positive patients suffer more frequent adverse effects to breast cancer treatment.
- To compare disease-free survival of HCV seropositive breast cancer patients vs. seronegative patients.
|Study Type :||Observational|
|Estimated Enrollment :||900 participants|
|Official Title:||Association of Hepatitis C Virus Seropositivity With Breast Cancer Prognosis and Treatment Outcome|
|Actual Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
The data of breast cancer patients treated at OCMU in the last 10 years will be retrieved from the hospital data filing system. All consecutive patients with biopsy-proven invasive breast cancer will be included.
A group of age-matched women from the same geographical distribution who are healthy volunteers or hospital patients without cancer diagnosis will serve as a control group for the HCV prevalence. We aim at a sample size with a study-to-control ratio of 1:3.
- Prevalence of HCV seropositivity in breast cancer patients. [ Time Frame: This outcome will be assessed through study completion, an average of 6 months. ]Proportion of patients with breast cancer with positive anti-HCV serological test.
- Disease-free survival. [ 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. ]Time from the date of breast cancer diagnosis to the date of last follow-up or the date of first breast cancer-related event.
- Overall survival. [ 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. ]Time from the date of breast cancer diagnosis to the date of last follow-up visit or the date of death.
- Tumor stage [ Time Frame: This outcome will be assessed through study completion, an average of 6 months. ]AJCC pathological stage on record.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090164
|Mansoura University Oncology Center|
|Mansourah, DK, Egypt, 35516|