The Registration Program of BRCA1/2 Gene

Chinese Anti-Cancer Association

Status: Unknown

Conditions: Breast Cancer

Treatments: Genetic: NGS test

Study type: Observational

Funder types: Other

Identifiers

NCT02593435

CBRCA

Details and patient eligibility

About

Purpose:

1. Screening of large samples is to search the gene mutation of the breast cancer susceptibility gene (BRCA1 and BRCA2) in Chinese high risk group.
2. To build the breast cancer BRCA1/2 mutation database of Chinese group.
3. To build the hazard model of breast cancer BRCA1/2 mutation of Chinese group.

Full description

It is the first large-scale and systematic study that fully recognize and review on the mutation spectrum of BRCA1/2 and the risk of Breast cancer in Chinese high risk group, it will be a Landmark research of susceptibility genes in Chinese breast cancer.

Enrollment: 8,000 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Chinese Genetic/Familial breast cancer patients, and its first or second degree relatives with breast cancer (female or male).

The selection will be based on NCCN Clinical Practice Guidelines in Oncology (Genetic/Familial High-Risk Assessment: Breast and Ovarian).

Inclusion Criteria:

Patients: it must be from independent family and meet the one or more of the following conditions.

1. Patients' age at diagnosis: 45 years or younger.

2. Patients' age at diagnosis: 50 years or younger.

3. Breast cancer patients: it must meet the one or more of the following family medical histories.

   3.1 Patients' age at diagnosis: 50 years or younger, and the one or more of the next of Kin has breast cancer.

   3.2 Patients' age at diagnosis: any of age, and the one or more of the next of Kin has breast cancer that its age at diagnosis was 50 years or younger.

   3.3 Patients' age at diagnosis: any of age, and the two or more of the next of Kin have breast cancer that its age at diagnosis was 50 years or younger.

   3.4 Patients' age at diagnosis: any of age, and the one or more of the next of Kin has epithelial ovarian cancer.

   3.5 Patients' age at diagnosis: any of age, and the two or more of the next of Kin have pancreatic cancer and/or prostate cancer (Gleason grading>7, any of age).

   3.6 Patients' age at diagnosis: any of age, and the one or more of the close-male relatives has breast cancer.

4. Triple negative patients' age of onset: 60 years or younger.

5. Patients: male and have breast cancer.

Patients' first or second degree relatives are BRCA1/2 mutation carrier (1-5 people):

First or second degree female adult relatives of patients (age: 18 years or older), it will be selected from the same paternal or maternal side according to the family disease.

First or second degree male relatives of patients have breast cancer.

Exclusion Criteria:

N/A.

Trial design

8,000 participants in 1 patient group

No treatment

Description:

There will be two groups, one is breast cancer patient group, another group inlude the first-degree relatives and second degree relatives of patients with BRCA1/2 mutation. All volunteers should provid tissue(s) and blood for NGS test.

Treatment:

Genetic: NGS test