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

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ClinicalTrials.gov Identifier: NCT00590109
Recruitment Status : Active, not recruiting
First Posted : January 10, 2008
Last Update Posted : January 3, 2018
Sponsor:
Collaborators:
Sarah Lawrence College
University of Washington
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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
Breast Cancer Other: Blood test Other: Questionnaire

Study Type : Observational
Estimated Enrollment : 5600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Germline BRCA1 and BRCA2 Mutations in Jewish Women Affected by Breast Cancer
Study Start Date : March 1997
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Group/Cohort 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.



Primary Outcome Measures :
  1. to further characterize inherited predisposition to breast cancer mediated by specific BRCA alleles among Jewish women. [ Time Frame: Conclusion of the study ]

Biospecimen Retention:   Samples With DNA
blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00590109     History of Changes
Other Study ID Numbers: 97-029
CA08748
First Posted: January 10, 2008    Key Record Dates
Last Update Posted: January 3, 2018
Last Verified: January 2018

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