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Association of Hepatitis C Virus With Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04090164
Recruitment Status : Active, not recruiting
First Posted : September 16, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Osama Hussein, Mansoura University

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.

Condition or disease
Breast Cancer Hepatitis C

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.

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Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
Study group
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.
Control group
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Tumor stage [ Time Frame: This outcome will be assessed through study completion, an average of 6 months. ]
    AJCC pathological stage on record.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Retrospective analysis of all consecuitive patients on Oncology Center of Mansoura University (OCMU) database.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090164


Locations
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Egypt
Mansoura University Oncology Center
Mansourah, DK, Egypt, 35516
Sponsors and Collaborators
Mansoura University
Publications of Results:

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Responsible Party: Osama Hussein, Professor of surgery (surgical oncology), Mansoura University
ClinicalTrials.gov Identifier: NCT04090164    
Other Study ID Numbers: R.18.02.34.R1.R2
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Osama Hussein, Mansoura University:
Breast cancer
Hepatitis C virus
Prognosis
Epidemiology
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Breast Neoplasms
Hepatitis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections