brca1 Mutation CarrierNCT00897455
Studying Breast Cancer Risk in Women Who Are BRCA1/BRCA2 Mutation Carriers
An observational study of brca1 Mutation Carrier and brca2 Mutation Carrier, run by Gynecologic Oncology Group at 1 site in United States.
Trial summary
RATIONALE: Studying samples of DNA in the laboratory from women who are BRCA1/BRCA2 mutation carriers may help doctors learn more about cancer and identify biomarkers related to cancer. PURPOSE: This research study is looking at breast cancer risk in women who are BRCA1/BRCA2 mutation carriers. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- brca1 Mutation Carrier, brca2 Mutation Carrier, Breast Cancer
- What is being tested?
- DNA analysis, mutation analysis and polymorphism analysis
- Type of treatment
- Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Dec 2009
- 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Known positive BRCA1/BRCA2 mutation carrier
- With or without a personal history of breast cancer prior to enrollment in clinical trial GOG-0199
- Currently enrolled in clinical trial GOG-0199 AND meets the following criteria:
- Completed baseline questionnaire (BQ-199)
- Provided information on prior breast cancer history, including date of diagnosis
- Provided complete data from the DNA analysis on the genetic variants of interest
- Signed an approved informed consent and authorization permitting release of personal health information
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, 20892-1182
Clinical Trials Office - Warren Grant Magnusen Clinical Center, 888-NCI-1937
About this study
Official title: Genetic Modifiers of BRCA1/BRCA2-Related Breast Cancer Risk in BRCA1/BRCA2 Mutation Carriers - CIMBA 5
RATIONALE: Studying samples of DNA in the laboratory from women who are BRCA1/BRCA2 mutation carriers may help doctors learn more about cancer and identify biomarkers related to cancer.
PURPOSE: This research study is looking at breast cancer risk in women who are BRCA1/BRCA2 mutation carriers.
Read the detailed description
OBJECTIVES:
- To identify potential genetic modifiers of breast cancer risk by contributing data and genetic information obtained from women who are BRCA1/BRCA2 mutation carriers enrolled in clinical trial GOG-0199 to an international consortium of clinical cancer genetics investigators (CIMBA).
OUTLINE: This is a multicenter study. Patients are stratified by study, country of residence, ethnicity, and birth cohort. Joint analyses of BRCA1 and BRCA2 mutation carriers are further stratified by mutation.
Previously collected DNA samples are analyzed for genetic variants in selected candidate genes (rs16942 in BRCA1, rs2237060 in RAD50, "SNP3", and rs2241193 in IGFBP5). The single nucleotide polymorphism (SNP) data from this study and selected demographic, clinical, and epidemiological data obtained from the baseline questionnaire administered in the GOG-0199 study are submitted to the Consortium of Investigators of Modifiers of BRCA-Associated Cancer (CIMBA) Central Database. The epidemiological and SNP data contributed to the Central Database are then distributed to the investigators responsible for analysis of a particular SNP or set of SNPs from a candidate gene or genetic pathway.
- Being tested
- DNA analysis, mutation analysis, polymorphism analysis, laboratory biomarker analysis, evaluation of cancer risk factors
- Keywords
- breast cancer, BRCA1 mutation carrier, BRCA2 mutation carrier
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNA analysisGenetic
mutation analysisGenetic
polymorphism analysisGenetic
laboratory biomarker analysisOther
evaluation of cancer risk factorsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of potential genetic modifiers of breast cancer risk
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startApr 2008
- Primary completionDec 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for brca1 Mutation CarrierStudies 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
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Mark H. Greene, MD, Study chair, Clinical Genetics BranchMichael Birrer, MD, PhD, NCI - Cell and Cancer Biology BranchPhuong Mai, MD, Clinical Genetics Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00897455
- Sponsor's protocol ID
- CDR0000598427
- Other IDs
- GOG-8008
- Status last verified
- Mar 2011
- First submitted
- 9 May 2009
- Last updated
- 23 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Modifiers of BRCA1/BRCA2-Related Breast Cancer Risk in BRCA1/BRCA2 Mutation Carriers - CIMBA 5
- ClinicalTrials.gov ID
- NCT00897455
- Acronym / sponsor ID
- CDR0000598427
- Keywords
- breast cancer, BRCA1 mutation carrier, BRCA2 mutation carrier
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2008
- Primary completion
- Dec 2009 (estimated)
- First posted
- 12 May 2009 (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.
RATIONALE: Studying samples of DNA in the laboratory from women who are BRCA1/BRCA2 mutation carriers may help doctors learn more about cancer and identify biomarkers related to cancer.
PURPOSE: This research study is looking at breast cancer risk in women who are BRCA1/BRCA2 mutation carriers.
Detailed description
OBJECTIVES:
- To identify potential genetic modifiers of breast cancer risk by contributing data and genetic information obtained from women who are BRCA1/BRCA2 mutation carriers enrolled in clinical trial GOG-0199 to an international consortium of clinical cancer genetics investigators (CIMBA).
OUTLINE: This is a multicenter study. Patients are stratified by study, country of residence, ethnicity, and birth cohort. Joint analyses of BRCA1 and BRCA2 mutation carriers are further stratified by mutation.
Previously collected DNA samples are analyzed for genetic variants in selected candidate genes (rs16942 in BRCA1, rs2237060 in RAD50, "SNP3", and rs2241193 in IGFBP5). The single nucleotide polymorphism (SNP) data from this study and selected demographic, clinical, and epidemiological data obtained from the baseline questionnaire administered in the GOG-0199 study are submitted to the Consortium of Investigators of Modifiers of BRCA-Associated Cancer (CIMBA) Central Database. The epidemiological and SNP data contributed to the Central Database are then distributed to the investigators responsible for analysis of a particular SNP or set of SNPs from a candidate gene or genetic pathway.
Study design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| DNA analysis | Genetic | – |
| mutation analysis | Genetic | – |
| polymorphism analysis | Genetic | – |
| laboratory biomarker analysis | Other | – |
| evaluation of cancer risk factors | Procedure or surgery | – |
Primary outcome
Identification of potential genetic modifiers of breast cancer risk
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2011.
Related trials for brca1 Mutation Carrier
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
RecruitingObservational study
Analysing Outcomes After Prostate Cancer Diagnosis and Treatment in Carriers of Rare Germline Mutations
Prostate Cancer
RecruitingPhase 3
The Cancer of the Pancreas Screening-5 CAPS5)Study
Pancreas Cancer, Peutz-Jeghers Syndrome (PJS)
Active, not recruitingPhase 1
INO 5401 Vaccination in BRCA1/2 Mutation Carriers
BRCA1/2 Mutation
Active, not recruiting
Prophylactic Salpingectomy With Delayed Oophorectomy
Ovarian Carcinoma
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.
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, United States
Mark H. Greene, MD study chair
Clinical Genetics Branch
Michael Birrer, MD, PhD
NCI - Cell and Cancer Biology Branch
Phuong Mai, MD
Clinical Genetics Branch
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 brca1 Mutation Carrier and brca2 Mutation Carrier, run by Gynecologic Oncology Group at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 23 Mar 2011. 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 United States. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of potential genetic modifiers of breast cancer risk. 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 23 Mar 2011.