The Registration Program of BRCA1/2 Gene

Breast Cancer Clinical Trial

— RCA  

Official title:

The Registration Program of BRCA1/2 Gene in Chinese Breast Cancer Group

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02593435
• Other study ID #: CBRCA
• Status: Recruiting
• Phase: N/A
• First received: October 29, 2015
• Last updated: March 22, 2016
• Start date: October 2015
• Est. completion date: December 2016

Study information

• Verified date: March 2016
• Source: Chinese Anti-Cancer Association
• Contact: Tao Wang, Doctor
• Phone: 86-139-1092-8773
• Email: wangtao6[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8000
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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:

Study Design

Observational Model: Family-Based, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Genetic:
• NGS test
To record the characteristic QC parameters and evaluate the detection performance of Next-Generation Sequencing (NGS), including coverage depth and sequence similarity, then be used to evaluate the quality of base recognition and alignment. To know mutation characteristic spectrum of BRCA1/2.

Locations

Country	Name	City	State
China	The 307th Hospital of Chinese People's Liberation Army	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese Anti-Cancer Association

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To build the database of the Chinese breast cancer BRCA1/2 mutation.		About 2 years	No
Secondary	To build the hazard model of Chinese breast cancer BRCA1/2 mutation.		About 2 years	No