Clinical Trial Record

Return to Clinical Trials

Clinical Outcomes in Hereditary Cancer


2006-01


2016-01


2016-01


0

Study Overview

Clinical Outcomes in Hereditary Cancer

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.

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.

  • Breast Cancer
  • Pancreatic Cancer
  • OTHER: Genotyping
  • 06-004

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2007-12-19  

N/A  

2016-01-27  

2007-12-19  

N/A  

2016-01-28  

2007-12-24  

N/A  

2016-01  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A


Allocation:
N/A


Interventional Model:
N/A


Masking:
N/A


Arms and Interventions

Participant Group/ArmIntervention/Treatment
: 1

Patients with breast and pancreas cancer.

OTHER: 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 t
Primary Outcome MeasuresMeasure DescriptionTime 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
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:

Accepts Healthy Volunteers:

    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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.


    • PRINCIPAL_INVESTIGATOR: Mark Robson, MD, Memorial Sloan Kettering Cancer Center

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available