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Germline BRCA1 and BRCA2 Mutations in Jewish Women Affected by Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Sarah Lawrence College
University of Washington
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00590109
First received: December 26, 2007
Last updated: January 31, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this project is to further characterize inherited predisposition to breast cancer mediated by specific BRCA alleles (BRACA1 185delAG and 5382insC; BRCA2 6174delT) among Jewish women.


Condition Intervention
Breast Cancer
 Other: Blood test
Other: Questionnaire

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Germline BRCA1 and BRCA2 Mutations in Jewish Women Affected by Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • to further characterize inherited predisposition to breast cancer mediated by specific BRCA alleles among Jewish women. [ Time Frame: Conclusion of the study ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

blood samples


Estimated Enrollment: 5600
Study Start Date: March 1997
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Other: Blood test
subjects will provide one 8ml blood sample drawn into one ACD tube and 16ml of blood drawn into two EDTA (purple top) tubes.
Other: Questionnaire
A questionnaire encompassing medical, environmental exposure, and reproductive history.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

A list of Jewish women diagnosed with breast cancer at Memorial Hospital after January 1994 will be generated from the hospital database. Patients that meet the study criteria will have a letter sent to their oncologist asking permission to invite the patient to participate in a study.

Criteria

Inclusion Criteria:

  • Patients are eligible for the study if they are over 18 years of age, identify their ancestry as Jewish (both Sephardic and Ashkenazi Jews are eligible), have or have had a diagnosis of breast cancer, and are able to give informed consent.
  • Relatives, age 18 or older, of the patients who meet eligibility criteria above and are found to have a specific BRCA1 or BRCA2 mutation if they are able to give informed consent.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00590109

Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Sarah Lawrence College
University of Washington
Investigators
Principal Investigator: Kenneth Offit, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00590109     History of Changes
Other Study ID Numbers: 97-029, CA08748
Study First Received: December 26, 2007
Last Updated: January 31, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
Breast Cancer
Jewish
BRCA1
BRCA2
97-029

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 22, 2013