Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments blood test, questionnaire
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator Sarah Lawrence College
Start date March 1997
End date December 2016
Trial size 5600 participants
Trial identifier NCT00590109, 97-029, CA08748

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.

Primary Outcomes

Measure
to further characterize inherited predisposition to breast cancer mediated by specific BRCA alleles among Jewish women.
time frame: Conclusion of the study

Eligibility Criteria

Female participants at least 19 years old.

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.

Additional Information

Official title Germline BRCA1 and BRCA2 Mutations in Jewish Women Affected by Breast Cancer
Principal investigator Kenneth Offit, MD
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.