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

Gastrointestinal Stromal Tumor Clinical Trial

Official title:

Genetic Risk Factors for Gastrointestinal Stromal Tumors (GIST)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00954655
• Other study ID #: ACOSOG-Z9081
• Secondary ID: ACOSOG-Z9081CDR0
• Status: Completed
• Start date: December 2008
• Est. completion date: April 2013

Study information

• Verified date: January 2019
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

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

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumor
• Gastrointestinal Stromal Tumors

Intervention

Genetic:
• mutation analysis

• polymorphism analysis

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	response		Up to 5 years