ClinicalTrials.gg
RecruitingNCT07558343MATADOR2Updated Oct 29, 2026

Male breAsT cAncer preDisposition Factor: Creation of a Control Cohort 2

An interventional study of Questionnaire completion and Genetic analysis (WES) in Male Breast Cancer, sponsored by Institut Claudius Regaud. Recruiting at 1 site in France. Open to male participants aged 66 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by Institut Claudius Regaud · Not applicable, Interventional, and Other

Updated Oct 29, 2026Now RecruitingSite recruiting status changedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Not applicable
Ages
66 Years and older
Sex
Male
01

Study summary

This is an interventional, prospective, single-center study designed to collect and describe genetic, environmental and psychosocial control data from male participants. The participants did not have any prior history of cancer at the time of the oncogenetic consultation and do not have the family mutation researched during the oncogenetic consultation (targeted genetic testing). The participants are referenced in the IUCT-O medical records as family members of patients suffering from male breast cancer.

The study will be conducted on a population of 120 participants.

02

Conditions studied

  • Male Breast Cancer

Keywords

  • breast cancer
  • predisposition factor
03

In context

Breast Neoplasms, Male

286 studies on the registry are indexed under Breast Neoplasms, Male; 5 are open to participants now.

This study's planned enrollment of 120 is above the median of 37 across 230 interventional studies indexed under Breast Neoplasms, Male.

Browse Breast Neoplasms, Male studies →

Lead sponsor

Institut Claudius Regaud is the lead sponsor of 117 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
66 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 1. A male volunteer participant with no personal history of cancer, registered in the IUCT-O oncogenetics database as a relative of a patient carrying a pathogenic or likely pathogenic variant in one of the cancer predisposition genes routinely analyzed at the oncogenetics laboratory
  • 2. Age ≥ 66 years
  • 3. Participant with no known family relationship to a patient of the MATADOR1 cohort
  • 4. Participant who has undergone an oncogenetic consultation at the IUCT-O
  • 5. Participant who does not carry the familial mutation in any of the cancer predisposition genes previously tested
  • 6. Participant for which an archived blood sample is available for the research in the oncogenetics laboratory
  • 7. Participant having signed an form before inclusion in the study and before any study specific procedure

Exclusion criteria

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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Other
    Control group

    The participants enrolled in this study (MATADOR2) will serve as control group for the patients enrolled in the previous study (MATADOR = MATADOR1) in order to identify: 1. the environmental and psychosocial predisposition factors 2. the genetic predisposition factors

    Other: Questionnaire completion · Other: Genetic analysis (WES)

Interventions

  • OtherQuestionnaire completion

    In order to meet the study's objective, after written informed consent was obtained, participants will be asked to complete a questionnaire characterizing their environmental and psychosocial context. The questionnaire is to be filled out by the participants at home. It is estimated that the questionnaire will take around 30 minutes to complete. Demographics data will also be collected from the medical records of included participants.

  • OtherGenetic analysis (WES)

    In order to meet the study's objective, after completion of the questionnaire, a genetic analysis (Whole Exome Sequencing) will be conducted on an archived blood sample collected during the initial oncogenetics consultation. The patient had given consent to this sample in order for the oncogenetics laboratory to perform the targeted genetic analysis (presence of family mutation). No additional blood sample will be collected for the purpose of this study.

06

What researchers measure

Primary outcomes

  1. The environmental and psychosocial data in the questionnaire will be described by the usual descriptive statistics.

    A 75-question questionnaire (created for the purposes of the MATADOR project) will cover such aspects as the participant's living conditions, professional situation, qualifications or level of education, social environment, early life and family environment, general health and recent significant events. For each question of the questionnaire: quantitative variables will be described by the median, minimum, maximum and number of missing data, and qualitative variables by the numbers, percentages and number of missing data.

    Time frame: 30 days approximately for each participant, 1 year and 1 month in total for all patients

Other outcomes

  1. The list of genetic variants of the participants will be otained through a WES (Whole Exome Sequencing) analysis

    Time frame: Through study completion, an average of 1 year

07

Study locations

1 of 1 sites recruiting
  • Institut Universitaire du Cancer Toulouse - Oncopole, Laboratoire d'oncogénétique
    Toulouse, 31059, France
    Recruiting
08

Updates

1 registry update since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 29, 2026
Sites
Institut Universitaire du Cancer Toulouse - Oncopole, Laboratoire d'oncogénétique is now Recruiting
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    Not yet recruiting→Recruiting
    Institut Universitaire du Cancer Toulouse - Oncopole, Laboratoire d'oncogénétique is now Recruiting
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07558343
Collaborators
Ligue contre le cancer, France
Responsible party
Sponsor
First posted
Apr 30, 2026
Start date
Oct 15, 2026 (estimated)
Primary completion
Oct 15, 2027 (estimated)
Completion
Oct 15, 2027 (estimated)
Last update
Oct 29, 2026

Study contacts

Ayman AL SAATI, PharmD, PhD
Contact
alsaati.ayman@iuct-oncopole.fr
0033 5 31 15 52 42

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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