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Clinical Outcomes in Hereditary Cancer

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ClinicalTrials.gov Identifier: NCT00580021
Recruitment Status : Withdrawn
First Posted : December 24, 2007
Last Update Posted : January 28, 2016
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief 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.


Condition or disease Intervention/treatment
Breast Cancer Pancreatic Cancer Other: Genotyping

Detailed 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.


Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Outcomes in Hereditary Cancer
Study Start Date : January 2006
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/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 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 Outcome Measures :
  1. 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 ]

Biospecimen Retention:   Samples With DNA
Once potential subjects are identified, pathology records will be reviewed to establish which of the potential subjects have archived pathology material available at MSKCC. It is important to note that the material does not have to be tumor and, in fact, benign tissue, such as uninvolved lymph node, will be sought by preference. However, tumor tissue will be used if no benign tissue is available.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The subjects will be individuals with the disease of interest during the time period of interest who described their religious preference at the time of registration to be Jewish.
Criteria

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.


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): NCT00580021


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
Investigators
Principal Investigator: Mark Robson, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00580021     History of Changes
Other Study ID Numbers: 06-004
First Posted: December 24, 2007    Key Record Dates
Last Update Posted: January 28, 2016
Last Verified: January 2016

Keywords provided by Memorial Sloan Kettering Cancer Center:
Ashkenazi ancestry
mutations in BRCA1 or BRCA2
Breast Cancer
Pancreatic Cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases