Overview

This trial is active, not recruiting.

Conditions breast cancer, pancreatic cancer
Treatment genotyping
Sponsor Memorial Sloan Kettering Cancer Center
Start date January 2006
End date January 2016
Trial size 376 participants
Trial identifier NCT00580021, 06-004

Summary

Compare the clinical characteristics and post-surgical outcomes (overall survival)of pancreatic cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 .

Compare the clinical characteristics and outcomes (time to progression) of breast cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 receiving paclitaxel chemotherapy for metastatic disease.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
Patients with breast and pancreas cancer.
genotyping
Samples for DNA extraction will be shaved from archival paraffin-embedded tissue blocks (using normal lymph node preferentially)and placed in appropriate receptacles labeled only with the subject unique study number. This material will be transported to the genotyping laboratory, where it will be stored until the clinical record abstraction is complete. Briefly, DNA will be extracted from the archive paraffin-embedded material using standard protocols and the samples will be analyzed for the presence of the Ashkenazi BRCA founder mutations using either PCR-based or gel-electrophoresis-based approaches.

Primary Outcomes

Measure
The overall objective of the protocol is to examine the hypothesis that hereditary cancers are distinct in clinical characteristics and outcome from those that arise in the absence of a known predisposition.
time frame: 2 years

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Included in DB0363-03 - Jewish religious preference at registration - Archival material available for testing - Adequate post-surgical follow-up - Jewish religious preference at registration - Archival material available for testing - Adequate follow-up to determine time to progression Exclusion Criteria: -Subjects will not be included in the analyses if a DNA sample cannot be obtained.

Additional Information

Official title Clinical Outcomes in Hereditary Cancer
Principal investigator Mark Robson, MD
Description Compare the clinical characteristics and post-surgical outcomes (overall survival)of pancreatic cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 . Compare the clinical characteristics and outcomes (time to progression) of breast cancer patients of Ashkenazi descent with or without germline founder mutations in BRCA1 or BRCA2 receiving paclitaxel chemotherapy for metastatic disease.
Trial information was received from ClinicalTrials.gov and was last updated in June 2015.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.