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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00590109

Collaborator

Sarah Lawrence College (Other), University of Washington (Other)

383

Enrollment

Location

297.7

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Other: Blood test Other: Questionnaire

Study Design

Study Type:

Observational

Actual Enrollment :

383 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Mar 1, 1997

Actual Primary Completion Date :

Dec 22, 2021

Actual Study Completion Date :

Dec 22, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

to further characterize inherited predisposition to breast cancer mediated by specific BRCA alleles among Jewish women. [through study completion, an average of 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.