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

NCT ID: NCT00590109

Last Updated: 2021-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

383 participants

Study Classification

OBSERVATIONAL

Study Start Date

1997-03-31

Study Completion Date

2021-12-22

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Keywords

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Breast Cancer Jewish BRCA1 BRCA2 97-029

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Blood test

Intervention Type OTHER

subjects will provide one 8ml blood sample drawn into one ACD tube and 16ml of blood drawn into two EDTA (purple top) tubes.

Questionnaire

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Questionnaire

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Sarah Lawrence College

OTHER

Sponsor Role collaborator

University of Washington

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kenneth Offit, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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CA08748

Identifier Type: -

Identifier Source: secondary_id

97-029

Identifier Type: -

Identifier Source: org_study_id