CanSeR-OGen: Contribution of Oncogenetics in Breast Cancer in Reunion Epidemiology of Breast Cancer in Reunion: Study of the Reunion Mutation on BRCA2

Sponsor
Centre Hospitalier Universitaire de la Réunion (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05898009
Collaborator
(none)
300
1
31

Study Details

Study Description

Brief Summary

In mainland France, breast cancer is the most common cancer in women, with an estimated incidence of over 58,000 new cases. Even if breast cancer is a cancer with a good prognosis, it is responsible for more than 12,000 deaths per year (first cause of death by cancer in women in France).

Breast cancer is a multifactorial disease, which results from the interaction between environmental, lifestyle, hormonal and genetic risk factors.

In Reunion, more than 400 cases of breast cancer are diagnosed annually. As in mainland France, it is by far the most common cancer in Reunionese women, and its incidence continues to increase significantly since the age-standardized incidence rate increased by 28% between 2007 and 2017 to establish at 64.2/100,000 AP.

Two studies carried out in patients carrying mutations in the breast-ovary predisposition genes in Reunion, showed that more than 50% of patients carrying BRCA mutation have a mutation specific to the Reunion population on the BRCA2 gene.

These two studies, which confirm the genetic specificities of Reunion already described in other pathologies (Mucoviscidosis or Friedreich's Ataxia), suggest that this mutation could have a significant frequency in patients with breast cancer. Thus, evaluating the prevalence of this mutation in patients with breast cancer in Réunion would make it possible to adapt the indications for access to the oncogenetics consultation and the associated preventive measures

Condition or Disease Intervention/Treatment Phase
  • Genetic: blood sample for BRCA2 mutation detection
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Contribution of Oncogenetics in Breast Cancer in Reunion Epidemiology of Breast Cancer in Reunion: Study of the Reunion Mutation on BRCA2
Anticipated Study Start Date :
Aug 22, 2023
Anticipated Primary Completion Date :
Mar 22, 2025
Anticipated Study Completion Date :
Mar 22, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: BRCA2 mutation detection

Genetic: blood sample for BRCA2 mutation detection
blood sample

Outcome Measures

Primary Outcome Measures

  1. determine the prevalence of the Réunion mutation in the BRCA2 gene (c.2612C>A mutation of exon 11) in the population of individuals residing in Réunion who are diagnosed with breast cancer. [inclusion day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Domiciled in Reunion at the time of the diagnosis

  • Who is diagnosed with a first breast cancer (in situ or invasive) confirmed by anatomopathological examination during the inclusion period Or Who is diagnosed with a second breast cancer (in situ or invasive) confirmed by pathological examination during the inclusion period, contralateral to the first or at least 5 years after remission of the first

  • Having agreed to participate in the study;

  • Affiliates or beneficiaries of a social security scheme

Exclusion Criteria:
  • Carriers of breast lymphoma,

  • Minor patients or patients under guardianship or curatorship

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de la Réunion

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de la Réunion
ClinicalTrials.gov Identifier:
NCT05898009
Other Study ID Numbers:
  • 2023/CHU/04
First Posted:
Jun 12, 2023
Last Update Posted:
Jun 12, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de la Réunion
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 12, 2023