NCT04090164

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2018

Completed
1.6 years until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 16, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
5 months until next milestone

Results Posted

Study results publicly available

October 19, 2020

Completed
Last Updated

October 19, 2020

Status Verified

September 1, 2020

Enrollment Period

9 months

First QC Date

January 14, 2018

Results QC Date

August 14, 2020

Last Update Submit

September 24, 2020

Conditions

Breast CancerHepatitis C

Keywords

Breast cancerHepatitis C virusPrognosisEpidemiology

Outcome Measures

Primary Outcomes (1)

  • Prevalence of HCV Seropositivity in Breast Cancer Patients.

    Percentage of patients with breast cancer with positive anti-HCV serological test.

    This outcome will be assessed through study completion, an average of 6 months.

Secondary Outcomes (1)

  • 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.

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Retrospective analysis of all consecuitive patients on Oncology Center of Mansoura University (OCMU) database.

You may qualify if:

  • Biopsy-proven invasive breast cancer.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Oncology Center

Al Mansurah, DK, 35516, Egypt

Location

Related Publications (3)

  • Su FH, Chang SN, Chen PC, Sung FC, Su CT, Yeh CC. Association between chronic viral hepatitis infection and breast cancer risk: a nationwide population-based case-control study. BMC Cancer. 2011 Nov 24;11:495. doi: 10.1186/1471-2407-11-495.

    PMID: 22115285BACKGROUND

  • Attallah AM, El-Far M, Abdelrazek MA, Omran MM, Mahmoud AZ, Khalifa HS, Ahmed MM, El-Dosoky I. HCV nonstructural protein 4 is associated with aggressiveness features of breast cancer. Breast Cancer. 2018 May;25(3):297-302. doi: 10.1007/s12282-017-0829-1. Epub 2017 Dec 28.

    PMID: 29285674BACKGROUND

  • El-Ghitany EM, Farghaly AG. Geospatial epidemiology of hepatitis C infection in Egypt 2017 by governorate. Heliyon. 2019 Aug 17;5(8):e02249. doi: 10.1016/j.heliyon.2019.e02249. eCollection 2019 Aug.

    PMID: 31463388BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsHepatitis C

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Limitations and Caveats

This is a retrospective study. Due to limited funding, a non-selected sample of Breast Cancer was compared to a historical control derived from the data of a previously published population study. Further studies are required.

Results Point of Contact

Title
Osama Hussein
Organization
Mansoura University
osamahussein@mans.edu.eg
00201099815110

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of surgery (surgical oncology)

Study Record Dates

First Submitted

January 14, 2018

First Posted

September 16, 2019

Study Start

September 1, 2019

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

October 19, 2020

Results First Posted

October 19, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)