Clinical Outcomes in Hereditary Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Outcomes in Hereditary Cancer

Conditions
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Breast Cancer, Pancreatic Cancer

Intervention / Treatment
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* Other: Genotyping


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with breast and pancreas cancer. | Other: Genotyping<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ashkenazi ancestry, mutations in BRCA1 or BRCA2, Breast Cancer, Pancreatic Cancer