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Genetic & Pathological Studies of BRCA1/BRCA2: Associated Tumors & Blood Samples

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01034033
Recruitment Status : Recruiting
First Posted : December 17, 2009
Last Update Posted : November 4, 2020
Sponsor:
Collaborators:
Breast Cancer Research Foundation
Susan G. Komen Breast Cancer Foundation
Information provided by (Responsible Party):
Stanford University

Study Description
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Brief Summary:
The purpose of this study is to try to understand the biology of development of breast, ovarian, fallopian tube, peritoneal or endometrial cancer from persons at high genetic risk for these diseases. The influence of environmental factors on cancer development in individuals and families will be studied. The efficacy of treatments for these diseases will be evaluated.

Condition or disease
Breast Cancer Ovarian Cancer Gynecologic Cancers Ovarian/Peritoneal/Fallopian Cancer

Detailed Description:
  1. To establish a demographic database to evaluate the efficacy of medical interventions in patients and relatives who carry BRCA1 and 2 mutations and to compare these outcomes to patients who do not carry a BRCA1 or 2 mutation.
  2. To obtain blood samples from patients who undergo genetic testing to a) evaluate the incidence of genetic modifier polymorphisms involved in the development of cancer in BRCA1 and 2 mutation carriers and to compare this incidence to non-BRCA 1 and 2 carriers. b) to understand the interaction of genetic modifiers and BRCA1 and 2 in the development of cancer. c) to determine the effect of environmental influences on the incidence of polymorphisms in genetic modifiers and on the penetrance of BRCA1 and 2 mutations by linking information from our demographic database to blood samples and
  3. To obtain tumor tissue from BRCA1 and 2 carriers to utilize for gene expression studies.
  4. To establish a cohort of sporadic breast cancer patients, or women with no family history of cancer in a first degree relative, to serve as a comparison group to women with strong family history of breast cancer.
  5. To establish a cohort of healthy volunteers without personal or family history of cancer to serve as a comparison group to women with sporadic and familial breast cancer.
Study Design
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Study Type : Observational
Estimated Enrollment : 3300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genetic & Pathological Studies of BRCA1/BRCA2: Associated Tumors & Blood Samples
Study Start Date : August 2001
Estimated Primary Completion Date : January 2099
Estimated Study Completion Date : January 2099

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Biospecimen Retention:   Samples With DNA
blood and breast tissues

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women who have a high risk of developing breast or ovarian cancer due to a known germline mutation in the BRCA1/2, PTEN, CDH1, or TP53 cancer susceptibility genes, or due to strong family history of either breast or ovarian cancer, in the absence of known cancer susceptibility gene mutation.
Criteria

Inclusion Criteria:

I. Women who have a high risk of developing breast or ovarian cancer due to a known germline mutation in the BRCA1/2, PTEN, CDH1, or TP53 cancer susceptibility genes, or due to strong family history of either breast or ovarian cancer, in the absence of known cancer susceptibility gene mutation.

II. Women who are approaching surgery for resection of a pelvic mass, which is considered suspicious for neoplasia by radiologic or clinical criteria; such women may or may not also meet criteria for inclusion in group I.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034033


Contacts
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Contact: Meredith Mills (650) 724-5223 bluett@stanford.edu

Locations
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United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Meredith Mills    650-724-5223    bluett@stanford.edu   
Principal Investigator: James M Ford         
Sub-Investigator: Allison Walsh Kurian         
Sponsors and Collaborators
Stanford University
Breast Cancer Research Foundation
Susan G. Komen Breast Cancer Foundation
Investigators
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Principal Investigator: James M Ford Stanford University
More Information
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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01034033    
Other Study ID Numbers: IRB-11872
SU-11022007-786 ( Other Identifier: Stanford University )
BRSNSTU0020 ( Other Identifier: OnCore )
First Posted: December 17, 2009    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stanford University:
quality of life