Association of Hepatitis C Virus With Breast Cancer

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.

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Key information

Conditions

Breast Cancer Blood-Borne Infections Breast Diseases Breast Neoplasms Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases Neoplasms Neoplasms by Site RNA Virus Infections Skin Diseases Skin and Connective Tissue Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Mansoura University Oncology Center

Al Mansurah, DK, 35516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Prevalence of HCV Seropositivity in Breast Cancer Patients.

Time frame: 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 outcomes

Disease-related Events

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.

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.

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Association of Hepatitis C Virus Seropositivity With Breast Cancer Prognosis and Treatment Outcome

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Sep 16, 2019
Registry last updated: Oct 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed