Male breAsT cAncer preDisposition Factor (MATADOR)

March 4, 2024 updated by: Institut Claudius Regaud

This is a non-interventional, prospective, single-center study designed to collect and describe environmental and psychosocial data from patients with a history of male breast cancer (MBC) referenced in the IUCT-O regional database.

The study will be conducted on a population of 110 to 150 patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with a history of male breast cancer (MBC) referenced in the IUCT-O's regional MutaFamily-MBC database.

Description

Inclusion Criteria:

  1. Male patient with a personal history of breast cancer
  2. Age ≥ 18 years
  3. Patient who has had an oncogenetic consultation at IUCT-O and is registered in the IUCT-O oncogenetic database
  4. Patient for whom no pathogenic variant has been detected on the HBOC panel (HBOC-)
  5. Patient with no objection to participation in the trial (for deceased patients: trusted support person with no objection to participation).

Exclusion Criteria:

1. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Male breast cancer
Other: Questionnaire completion

To meet the study's objective, patients will be asked to complete a questionnaire characterizing their environmental and psychosocial context.

The questionnaire is to be completed by the patients themselves, or by their trusted support person as recorded in their medical records (in the particular case of a deceased patient).

It is estimated that the questionnaire will take around 30 minutes to complete.

Data will also be collected from the medical records of included patients:

  • Demographics
  • Disease data

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The environmental data in the questionnaire will be described by the usual descriptive statistics.
Time Frame: 15 days for each patient

A 75-question questionnaire will cover such aspects as the patient's living conditions, professional situation, qualifications or level of education, social environment, early life and family environment, general health and recent significant events.

Quantitative data will be described by the median, minimum, maximum and number of missing data, and qualitative data by the numbers, percentages and number of missing data for each modality.
15 days for each patient
Psychosocial data from the questionnaire will be described using standard descriptive statistics.
Time Frame: 15 days for each patient

A 75-question questionnaire will cover such aspects as the patient's living conditions, professional situation, qualifications or level of education, social environment, early life and family environment, general health and recent significant events.

Quantitative data will be described by the median, minimum, maximum and number of missing data, and qualitative data by the numbers, percentages and number of missing data for each modality.
15 days for each patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Claudius Regaud

Collaborators

Ligue contre le cancer, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

January 12, 2024

First Posted (Actual)

January 23, 2024

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 23 SEIN 02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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