Breast CancerRCANCT02593435
The Registration Program of BRCA1/2 Gene
An observational study of Breast Cancer, run by Chinese Anti-Cancer Association at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- NGS test
- How many people
- 8,000 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Dec 2016
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Chinese Breast Cancer Patients
Who may be able to join
- 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.
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- 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.
Who cannot join
- N/A.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The 307th Hospital of Chinese People's Liberation Army
Beijing, Beijing Municipality, 100071
Tao Wang, Doctor, +86-139-1092-8773, wangtao6@hotmail.com
Shu-Juan Li, 86-010-6694-7798, lsjhe12345@163.com
About this study
Official title: The Registration Program of BRCA1/2 Gene in Chinese Breast Cancer Group
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- NGS test
- Keywords
- BRCA1/2 gene mutation, Breast Cancer, Chinese high risk group
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: NGS test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening of large samples is to search the gene mutation of the breast cancer susceptibility gene (BRCA1 and BRCA2) in Chinese high risk group.
Measured: About 2 years
Secondary outcomes (2)
To build the database of the Chinese breast cancer BRCA1/2 mutation.
Measured: About 2 years
To build the hazard model of Chinese breast cancer BRCA1/2 mutation.
Measured: About 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 8,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Chinese Anti-Cancer Association
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ze-Fei Jiang, Doctor, Principal investigator, 307 Hospital of PLA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593435
- Sponsor's protocol ID
- CBRCA
- Acronym
- RCA
- Status last verified
- Mar 2016
- First submitted
- 29 Oct 2015
- Last updated
- 24 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: The data-sharing of the volunteers' genetic information need be discussed more.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Registration Program of BRCA1/2 Gene in Chinese Breast Cancer Group
- ClinicalTrials.gov ID
- NCT02593435
- Acronym / sponsor ID
- RCA / CBRCA
- Conditions
- Breast Cancer
- Keywords
- BRCA1/2 gene mutation, Breast Cancer, Chinese high risk group
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Chinese Anti-Cancer AssociationUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 2 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | Genetic: NGS testThere 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Chinese Breast Cancer Patients
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (1 listed)
- N/A.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NGS testTo 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. | Genetic | No treatment |
Primary outcome
Screening of large samples is to search the gene mutation of the breast cancer susceptibility gene (BRCA1 and BRCA2) in Chinese high risk group.
Time frame: About 2 years
2 secondary outcomes
To build the database of the Chinese breast cancer BRCA1/2 mutation.
Time frame: About 2 years
To build the hazard model of Chinese breast cancer BRCA1/2 mutation.
Time frame: About 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2016.
- Individual participant dataSharing planned: Undecided. The data-sharing of the volunteers' genetic information need be discussed more.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ze-Fei Jiang, Doctor principal investigator
307 Hospital of PLA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Chinese Anti-Cancer Association at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tao Wang, Doctor (86-139-1092-8773, wangtao6@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: About 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2016.