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

NCT05898009 | Recruiting DMC

• 1 other identifier: 2023/CHU/04
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer; Genetic Disease; BRCA2 Mutation

Keywords

reunion

Outcome Measures

Primary Outcomes (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

Study Arms (1)

BRCA2 mutation detection

EXPERIMENTAL

Genetic: blood sample for BRCA2 mutation detection

Interventions

blood sample for BRCA2 mutation detection GENETIC

blood sample

BRCA2 mutation detection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Domiciled in Reunion at the time of the diagnosis
• Having agreed to participate in the study;
• Affiliates or beneficiaries of a social security scheme

You may not qualify if:

• Carriers of breast lymphoma,
• Minor patients or patients under guardianship or curatorship

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Study Sites (1)

Mireille IRABE

Saint-Pierre, 97432, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Genetic Diseases, Inborn

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Mireille IRABE

CONTACT

0262906283; mireille.irabe@chu-reunion.FR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 12, 2023
• Study Start: October 19, 2023
• Primary Completion: March 22, 2025
• Study Completion: March 22, 2026
• Last Updated: August 22, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)