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

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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

Tracking Information
First Submitted Date December 16, 2009
First Posted Date December 17, 2009
Last Update Posted Date November 4, 2020
Study Start Date August 2001
Estimated Primary Completion Date January 2099   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Genetic & Pathological Studies of BRCA1/BRCA2: Associated Tumors & Blood Samples
Official Title Genetic & Pathological Studies of BRCA1/BRCA2: Associated Tumors & Blood Samples
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
blood and breast tissues
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.
Condition
  • Breast Cancer
  • Ovarian Cancer
  • Gynecologic Cancers
  • Ovarian/Peritoneal/Fallopian Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 6, 2019)
3300
Original Estimated Enrollment
 (submitted: December 16, 2009)
500
Estimated Study Completion Date January 2099
Estimated Primary Completion Date January 2099   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Meredith Mills (650) 724-5223 bluett@stanford.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01034033
Other Study ID Numbers IRB-11872
SU-11022007-786 ( Other Identifier: Stanford University )
BRSNSTU0020 ( Other Identifier: OnCore )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Stanford University
Study Sponsor Stanford University
Collaborators
  • Breast Cancer Research Foundation
  • Susan G. Komen Breast Cancer Foundation
Investigators
Principal Investigator: James M Ford Stanford University
PRS Account Stanford University
Verification Date August 2020