Study of Tumor Samples in Patients Undergoing Treatment for Gastrointestinal Stromal Tumors on Clinical Trial ACOSOG-Z9001

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2015 by Alliance for Clinical Trials in Oncology
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00954655
First received: August 6, 2009
Last updated: July 23, 2015
Last verified: July 2015

August 6, 2009
July 23, 2015
December 2008
January 2100   (final data collection date for primary outcome measure)
response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
Polymorphisms in selected genes in relation to specific mutations and types of mutation in the c-kit gene [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00954655 on ClinicalTrials.gov Archive Site
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Study of Tumor Samples in Patients Undergoing Treatment for Gastrointestinal Stromal Tumors on Clinical Trial ACOSOG-Z9001
Genetic Risk Factors for Gastrointestinal Stromal Tumors (GIST)

RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking at tumor samples in patients undergoing treatment for gastrointestinal stromal tumors on clinical trial ACOSOG-Z9001.

OBJECTIVES:

Primary

  • To examine polymorphisms in selected genes involved in the detoxifying/metabolizing and DNA repair pathways in relation to specific mutations and types of mutation in the c-kit gene in tumor tissue from patients with gastrointestinal tumors (GIST) undergoing treatment on clinical trial ACOSOG-Z9001.

Secondary

  • To examine approximately 758 polymorphisms among candidate genes involved in detoxification/metabolism, cell cycle control, and DNA damage/repair in relation to specific mutations and types of mutation in the c-kit gene in tumor tissue from GIST patients for hypothesis generation. (exploratory)
  • To conduct an exploratory analysis of the polymorphism distribution in these patients. (exploratory)
  • To examine the association between the above polymorphisms and major toxicity (Grade 3/4) of adjuvant imatinib mesylate. (exploratory)

OUTLINE: Tumor samples are used for polymorphism and mutation analysis.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Tumor samples from patients with gastrointestinal stromal tumors enrolled on clinical trial ACOSOG-Z9001

Gastrointestinal Stromal Tumor
  • Genetic: mutation analysis
  • Genetic: polymorphism analysis
  • Other: laboratory biomarker analysis
Group 1
Tumor samples are used for polymorphism and mutation analysis.
Interventions:
  • Genetic: mutation analysis
  • Genetic: polymorphism analysis
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
374
Not Provided
January 2100   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Tumor samples from patients with gastrointestinal stromal tumors enrolled on clinical trial ACOSOG-Z9001
Both
18 Years and older
No
Contact: Lawrence Engel, MD engell@mskcc.org
United States
 
NCT00954655
ACOSOG-Z9081, ACOSOG-Z9081, CDR0000631512
Not Provided
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Lawrence Engel, MD Memorial Sloan Kettering Cancer Center
Alliance for Clinical Trials in Oncology
July 2015

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