The Registration Program of BRCA1/2 Gene

• Conditions: Breast Cancer
• Interventions: Genetic: NGS test

• Registration Number: NCT02593435
• Lead Sponsor: Chinese Anti-Cancer Association

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-29
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-11-01
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-22
• Last Update Posted: 2016-03-24
• Primary Completion: 2016-06
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 8000

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No treatment	NGS test	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.

Primary Outcome Measures

Name	Time	Method
Screening of large samples is to search the gene mutation of the breast cancer susceptibility gene (BRCA1 and BRCA2) in Chinese high risk group.	About 2 years

Secondary Outcome Measures

Name	Time	Method
To build the database of the Chinese breast cancer BRCA1/2 mutation.	About 2 years
To build the hazard model of Chinese breast cancer BRCA1/2 mutation.	About 2 years

Trial Locations

Locations (1)

The 307th Hospital of Chinese People's Liberation Army; 🇨🇳 Beijing, Beijing, China