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

This study is currently recruiting participants.
Verified November 2012 by Stanford University
Sponsor:
Collaborator:
Department of Defense
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01034033
First received: December 16, 2009
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
  Purpose
  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.

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:

U.S. FDA Resources

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: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
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
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
Department of Defense
Investigators
Principal Investigator: James M Ford Stanford University
  More Information

No publications provided

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: November 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
quality of life

Additional relevant MeSH terms:
Breast Neoplasms
Ovarian Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Endocrine Gland Neoplasms
 Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on May 23, 2013