NCT02593435

Brief Summary

Purpose:

  1. 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. 2.To build the breast cancer BRCA1/2 mutation database of Chinese group.
  3. 3.To build the hazard model of breast cancer BRCA1/2 mutation of Chinese group.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
8,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

October 29, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 2, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 24, 2016

Status Verified

March 1, 2016

Enrollment Period

8 months

First QC Date

October 29, 2015

Last Update Submit

March 22, 2016

Conditions

Breast Cancer

Keywords

BRCA1/2 gene mutationBreast CancerChinese high risk group

Outcome Measures

Primary Outcomes (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.

    About 2 years

Secondary Outcomes (2)

  • 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

Study Arms (1)

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

NGS testGENETIC

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.

No treatment

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Chinese Breast Cancer Patients

You may qualify if:

  • 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.
  • Patients' age at diagnosis: 50 years or younger, and the one or more of the next of Kin has breast cancer.
  • 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.
  • 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.
  • Patients' age at diagnosis: any of age, and the one or more of the next of Kin has epithelial ovarian cancer.
  • 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).
  • 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.

You may not qualify if:

  • N/A.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The 307th Hospital of Chinese People's Liberation Army

Beijing, Beijing Municipality, 100071, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The samples, both tissue(s) and blood of patients should be provided for NGS test after ICF being signed

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Ze-Fei Jiang, Doctor

    307 Hospital of PLA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Wang, Doctor

CONTACT

86-139-1092-8773wangtao6@hotmail.com

Zheng Jiang

CONTACT

86-010-6694-7016keyan307@163.com

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Target Duration
3 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2015

First Posted

November 2, 2015

Study Start

October 1, 2015

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

March 24, 2016

Record last verified: 2016-03

Locations

CN(1)