Clinical trial · Observational
The Registration Program of BRCA1/2 Gene
The Registration Program of BRCA1/2 Gene in Chinese Breast Cancer Group
NCT02593435CI-TRIAL-00021482RCAunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NGS test | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- No treatment
- description
- 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.
- interventionNames
- Genetic: NGS test
Primary outcomes (1)
- 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 (2)
- measure
- To build the database of the Chinese breast cancer BRCA1/2 mutation.
- timeFrame
- About 2 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.