Association of Hepatitis C Virus Seropositivity With Breast Cancer Prognosis and Treatment Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 650
- 试验地点
- 1
- 主要终点
- Prevalence of HCV Seropositivity in Breast Cancer Patients.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Biopsy-proven invasive breast cancer.
排除标准
- •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.
结局指标
主要结局
Prevalence of HCV Seropositivity in Breast Cancer Patients.
时间窗: 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.
次要结局
- 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.)
研究者
Osama Hussein
Professor of surgery (surgical oncology)
Mansoura University