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Clinical Trials/NCT06219187
NCT06219187CompletedNot Applicable

Male breAsT cAncer preDisposition Factor

Institut Claudius Regaud1 site in 1 country93 target enrollmentStarted: February 8, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
93
Locations
1
Primary Endpoint
Psychosocial data from the questionnaire will be described using standard descriptive statistics.

Study Overview

Brief Summary

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 Design

Study Type
Observational
Observational Model
Other
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Male patient with a personal history of breast cancer
  • Age ≥ 18 years
  • Patient who has had an oncogenetic consultation at IUCT-O and is registered in the IUCT-O oncogenetic database
  • Patient for whom no pathogenic variant has been detected on the HBOC panel (HBOC-)
  • 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).

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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