Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00954655
First received: August 6, 2009
Last updated: August 8, 2009
Last verified: August 2009

August 6, 2009
August 8, 2009
December 2008
June 2009   (final data collection date for primary outcome measure)
Polymorphisms in selected genes in relation to specific mutations and types of mutation in the c-kit gene [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00954655 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Not Provided
Not Provided
Not Provided
Not Provided
Not Provided
Gastrointestinal Stromal Tumor
  • Genetic: mutation analysis
  • Genetic: polymorphism analysis
  • Other: laboratory biomarker analysis
Not Provided
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
374
Not Provided
June 2009   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00954655
CDR0000631512, ACOSOG-Z9081
Not Provided
Not Provided
American College of Surgeons
National Cancer Institute (NCI)
Study Chair: Lawrence Engel Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
August 2009

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