Clinical Outcomes in Hereditary Cancer

NCT00580021 | Withdrawn

• 1 other identifier: 06-004
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Pancreatic Cancer

Keywords

Ashkenazi ancestry; mutations in BRCA1 or BRCA2; Breast Cancer; Pancreatic Cancer

Outcome Measures

Primary Outcomes (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.

  2 years

Study Arms (1)

1

Patients with breast and pancreas cancer.

Other: Genotyping

Interventions

Genotyping OTHER

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Subjects will not be included in the analyses if a DNA sample cannot be obtained.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

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.

MeSH Terms

Conditions

Breast Neoplasms; Pancreatic Neoplasms; Fanconi Anemia, Complementation Group D1

Interventions

Genotype

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Study Officials

• Mark Robson, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 24, 2007
• Study Start: January 1, 2006
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 28, 2016

Record last verified: 2016-01

Locations

US (1)