Male breAsT cAncer preDisposition Factor: Creation of a Control Cohort 2 (MATADOR2)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Ayman AL SAATI, PharmD, PhD
- Telefonnummer: 0033 5 31 15 52 42
- E-post: alsaati.ayman@iuct-oncopole.fr
Studieorter
-
-
-
Toulouse, Frankrike, 31059
- Institut Universitaire du Cancer Toulouse - Oncopole, Laboratoire d'oncogénétique
-
Kontakt:
- Ayman AL SAATI, PharmD, PhD
- Telefonnummer: 0033 5 31 15 52 20
- E-post: alsaati.ayman@iuct-oncopole.fr
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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 informed consent form before inclusion in the study and before any study specific procedure
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).
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Övrig: 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:
|
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.
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
The environmental and psychosocial data in the questionnaire will be described by the usual descriptive statistics.
Tidsram: 30 days approximately for each participant, 1 year and 1 month in total for all patients
|
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.
|
30 days approximately for each participant, 1 year and 1 month in total for all patients
|
Andra resultatmått
Resultatmått |
Tidsram |
|---|---|
|
The list of genetic variants of the participants will be otained through a WES (Whole Exome Sequencing) analysis
Tidsram: Through study completion, an average of 1 year
|
Through study completion, an average of 1 year
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Neoplasmer
- Hudsjukdomar
- Bröstsjukdomar
- Hud- och bindvävssjukdomar
- Bröstneoplasmer
- Bröstneoplasmer, manliga
- Undersökningstekniker
- Kliniska laboratorietekniker
- Diagnostiska tekniker och procedurer
- Diagnos
- Vårdtjänster
- Sjukvårdsanläggningar och tjänster
- Förebyggande hälsovårdstjänster
- Genetiska tekniker
- Genetiska tjänster
- Diagnostiska tjänster
- Genetisk testning
Andra studie-ID-nummer
- 26 SEIN 02
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .