Association of Hepatitis C Virus With Breast Cancer

An observational study of Breast Cancer and Hepatitis C, run by Mansoura University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Breast Cancer, Hepatitis C
How many people: 650 participants
Where: 1 siteEgypt
Study dates: 1 Sep 2019to 1 Jun 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
Healthy volunteers accepted
Adult, Older adult

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

Who may be able to join

Biopsy-proven invasive breast cancer.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Mansoura University Oncology Center
Al Mansurah, DK, 35516

Other trials in Egypt

About this study

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

Read the 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:

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.

Conditions: Breast Cancer, Hepatitis C
Keywords: Breast cancer, Hepatitis C virus, Prognosis, Epidemiology
Medical subject headings: Breast Neoplasms, Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04090164
Study group	Role	What they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

Prevalence of HCV Seropositivity in Breast Cancer Patients.
Percentage of patients with breast cancer with positive anti-HCV serological test.
Measured: This outcome will be assessed through study completion, an average of 6 months.

Secondary outcomes (1)

Disease-related Events
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.
Measured: at the date of last patients' visit recorded on her file. Patients should be censored at least 12 months from the time of diagnosis.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20191 Jun 2020

First posted16 Sep 2019
Study start1 Sep 2019
Primary completion1 Jun 2020
Study completion1 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by Mansoura UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Retrospective
Enrolment: 650 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04090164
Sponsor's protocol ID: R.18.02.34.R1.R2
Status last verified: Sep 2020
First submitted: 14 Jan 2018
Last updated: 19 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 22115285
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.
PubMed 29285674
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.
PubMed 31463388

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Association of Hepatitis C Virus Seropositivity With Breast Cancer Prognosis and Treatment Outcome
ClinicalTrials.gov ID: NCT04090164
Acronym / sponsor ID: R.18.02.34.R1.R2
Conditions: Breast Cancer, Hepatitis C
Keywords: Breast cancer, Hepatitis C virus, Prognosis, Epidemiology
Study type: Observational
Recruitment status: Completed
Enrolment: 650 participants (actual)
Lead sponsor: Mansoura UniversityUniversity, hospital or other
Study start: 1 Sep 2019 (actual)
Primary completion: 1 Jun 2020 (actual)
Study completion: 1 Jun 2020 (actual)
First posted: 16 Sep 2019 (actual)
Results: Posted 19 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 design

Observational model: Case-control
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
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.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Retrospective analysis of all consecuitive patients on Oncology Center of Mansoura University (OCMU) database.

Key inclusion criteria (1 listed)

Biopsy-proven invasive breast cancer.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

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.

1 secondary outcome

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.

Results and safety

Results posted to the registry on 19 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Group	650	405
Dakahlia Governorate Adult Female Population	145	145

Primary outcome: Prevalence of HCV Seropositivity in Breast Cancer Patients.

Time frame: This outcome will be assessed through study completion, an average of 6 months.. Count of participants. Unit: Participants

Measure	Study Group n = 405	Dakahlia Governorate Adult Female Population n = 145
anti-HCV Seropositive	88	15
anti-HCV seronegative	317	130

Study Group vs Dakahlia Governorate Adult Female Population: Odds Ratio (OR): 2.406 (95% CI 1.341 to 4.316), p = 0.0027, Fisher Exact
Study Group vs Dakahlia Governorate Adult Female Population: Odds Ratio (OR): 7.032 (95% CI 1.582 to 31.25), p = 0.0034, Fisher Exact

1 secondary outcome is reported in the full results.

Adverse events

Time frame: All-cause Mortality and Adverse Events were not assessed in this Retrospective, observational study.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Group	0 of 0	0 of 0	0

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22115285Su 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.
Background: PubMed 29285674Attallah 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.
Background: PubMed 31463388El-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.
Individual participant dataSharing planned: No

Related trials for Breast Cancer

Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
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RecruitingPhase 3
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TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Cancer and Hepatitis C, run by Mansoura University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of HCV Seropositivity in Breast Cancer Patients. (time frame: This outcome will be assessed through study completion, an average of 6 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04090164, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2020; AzTrials last refreshed its copy on 8 Nov 2026.