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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Stanford University
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01034033
First received: December 16, 2009
Last updated: July 12, 2016
Last verified: July 2016
  Purpose
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
Breast Cancer
Ovarian Cancer
Gynecologic Cancers
Ovarian/Peritoneal/Fallopian Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Genetic & Pathological Studies of BRCA1/BRCA2: Associated Tumors & Blood Samples

Resource links provided by NLM:


Further study details as provided by Stanford University:

Biospecimen Retention:   Samples With DNA
blood

Estimated Enrollment: 1500
Study Start Date: August 2001
Estimated Study Completion Date: January 2099
Estimated Primary Completion Date: January 2099 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01034033

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

Locations
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: Hanlee P. Ji         
Sub-Investigator: Vandana Bhardwaj Sharma         
Sub-Investigator: Patrick O. Brown         
Sub-Investigator: Maria Gramatges         
Sub-Investigator: Allison Walsh Kurian         
Sponsors and Collaborators
Stanford University
United States Department of Defense
Investigators
Principal Investigator: James M Ford Stanford University
  More Information

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01034033     History of Changes
Other Study ID Numbers: BRSNSTU0020  76102  SU-11022007-786 
Study First Received: December 16, 2009
Last Updated: July 12, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
quality of life

ClinicalTrials.gov processed this record on July 28, 2016