The Registration Program of BRCA1/2 Gene | NCT02593435

Studies
The Registration Program of BRCA1/2 Gene

NCT02593435

Sponsor

Chinese Anti-Cancer Association

Status

Unknown status

Last Update Posted

Mar 24, 2016Estimated

Enrollment

8,000Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

NGS test

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2015

Primary Completion Date

Jun 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Oct 29, 2015

First Submission Date that Met QC Criteria

Oct 29, 2015

First Posted Date

Nov 2, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2016

Last Update Posted Date

Mar 24, 2016Estimated

Description Module

Brief Summary

Purpose:

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

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No treatment		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.	Genetic: NGS test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NGS test	Genetic	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.

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Eligibility Module

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.

Patients' age at diagnosis: 45 years or younger.
Patients' age at diagnosis: 50 years or younger.
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.
Triple negative patients' age of onset: 60 years or younger.
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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Chinese Breast Cancer Patients

Sampling Method

Probability Sample

Name	Role	Phone	Extension	Email
Tao Wang, Doctor	Contact	86-139-1092-8773		wangtao6@hotmail.com
Zheng Jiang	Contact	86-010-6694-7016		keyan307@163.com

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases