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
  Purpose

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 Intervention
Breast Cancer
Pancreatic Cancer
Other: Genotyping

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Clinical Outcomes in Hereditary Cancer

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • 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 ]

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.


Estimated Enrollment: 376
Study Start Date: January 2006
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00580021     History of Changes
Other Study ID Numbers: 06-004
Study First Received: December 19, 2007
Last Updated: June 2, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 21, 2014