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

NCT00590109 | Completed

• 2 other identifiers: 97-029CA08748
• Study Type: observational
• Target: 383
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Jewish; BRCA1; BRCA2; 97-029

Outcome Measures

Primary Outcomes (1)

• to further characterize inherited predisposition to breast cancer mediated by specific BRCA alleles among Jewish women.

  through study completion, an average of 1 year

Study Arms (1)

1

Other: Blood test; Other: Questionnaire

Interventions

Blood test OTHER

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

1

Questionnaire OTHER

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

1

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• Sarah Lawrence College: collaborator
• University of Washington: collaborator

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Hematologic Tests; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Kenneth Offit, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 10, 2008
• Study Start: March 1, 1997
• Primary Completion: December 22, 2021
• Study Completion: December 22, 2021
• Last Updated: December 28, 2021

Record last verified: 2021-12

Locations

US (1)