Clinical Outcomes in Hereditary Cancer

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00580021

Enrollment

Registered

2007-12-24

Start date

2006-01-31

Completion date

2016-01-31

Last updated

2016-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Pancreatic Cancer

Keywords

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

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.

Detailed description

Interventions

OTHERGenotyping

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.

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026