Clinical trial NCT02593435: The Registration Program of BRCA1/2 Gene
Official title: The Registration Program of BRCA1/2 Gene in Chinese Breast Cancer Group
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: BRCA1/2 gene mutation
Breast Cancer
Chinese high risk group
Lead sponsor: Chinese Anti-Cancer Association
Sponsor class: OTHER
First posted: 2015-11-01
Enrollment: 8000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese Breast Cancer Patients

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.

Eligibility 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.

Primary outcomes:
measure: Screening of large samples is to search the gene mutation of the breast cancer susceptibility gene (BRCA1 and BRCA2) in Chinese high risk group.
timeFrame: About 2 years
Secondary outcomes:
measure: To build the database of the Chinese breast cancer BRCA1/2 mutation.
timeFrame: About 2 years
measure: To build the hazard model of Chinese breast cancer BRCA1/2 mutation.
timeFrame: About 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: The 307th Hospital of Chinese People's Liberation Army
state: Beijing
Study officials:
affiliation: 307 Hospital of PLA
name: Ze-Fei Jiang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: