Clinical Outcomes in Hereditary Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00580021
First received: December 19, 2007
Last updated: June 2, 2014
Last verified: June 2014

December 19, 2007
June 2, 2014
January 2006
January 2016   (final data collection date for primary outcome 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00580021 on ClinicalTrials.gov Archive Site
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Clinical Outcomes in Hereditary Cancer
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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

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.

Probability Sample

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.

  • Breast Cancer
  • Pancreatic 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.
1
Patients with breast and pancreas cancer.
Intervention: Other: Genotyping
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
376
January 2016
January 2016   (final data collection date for primary outcome measure)

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.

Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00580021
06-004
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Mark Robson, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP