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NCT00590109 Clinical Trial

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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00590109
Other study ID # 97-029
Secondary ID CA08748
Status Completed
Phase
First received
Last updated
Start date March 1997
Est. completion date December 22, 2021

Study information
Verified date December 2021
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 383
Est. completion date December 22, 2021
Est. primary completion date December 22, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 19 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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.
• Questionnaire
A questionnaire encompassing medical, environmental exposure, and reproductive history.

Locations
Country Name City State
United States Memorial Sloan Kettering Cancer Center New York New York

Sponsors (3)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center Sarah Lawrence College, University of Washington

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary to further characterize inherited predisposition to breast cancer mediated by specific BRCA alleles among Jewish women. through study completion, an average of 1 year
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