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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)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00954655
Enrollment
1
Registered
2009-08-07
Start date
2008-12-31
Completion date
2013-04-30
Last updated
2019-01-30

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

Conditions

Gastrointestinal Stromal Tumor

Keywords

gastrointestinal stromal tumor

Brief summary

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.

Detailed description

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.

Interventions

GENETICmutation analysis
GENETICpolymorphism analysis
OTHERlaboratory biomarker analysis

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Tumor samples from patients with gastrointestinal stromal tumors enrolled on clinical trial ACOSOG-Z9001

Design outcomes

Primary

MeasureTime frame
responseUp to 5 years

Countries

United States

Outcome results

None listed

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