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A Retrospective Study of C-kit Mutation Status in Asian Patients With Advanced Gastro-intestinal Stromal Tumors (GIST) Treated With Imatinib.

This study is not yet open for participant recruitment.
Verified October 2010 by National University Hospital, Singapore
Sponsor:
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT01227746
First received: October 21, 2010
Last updated: October 22, 2010
Last verified: October 2010
History of Changes
  Purpose

Imatinib is the current standard treatment for advanced GIST. Previous studies have shown that GIST genotype was associated with treatment outcomes with exon 11 having superior outcome compared with exon 9 or WT.10, 11 In patients with exon 9 kit mutation, the response rate was higher at when imatinib was given at 800mg daily compared with the standard dose of 400mg daily. Although the data linking tyrosine kinase mutation status and imatinib response in metastatic GISTs is intriguing, more information is needed before mutation testing is adopted as part of the routine analysis of high-risk or overtly malignant KIT-expressing GISTs.25 Despite the fact that exon 9 mutations are associated with a lower response rate, overall survival does not appear to be better with high-dose therapy. The investigators propose to conduct a retrospective analysis of mutational analysis on patients with GIST and determine the relationship between patient response and imatinib dose.


Condition Intervention
Asian Patients With Advanced Gastro-intestinal Stromal Tumors (GIST) Treated With Imatinib
 Procedure: Tumor biopsies

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by National University Hospital, Singapore:

Study Start Date: July 2010
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Tumor biopsies Procedure: Tumor biopsies

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Asian patients with advanced gastro-intestinal stromal tumors (GIST) treated with imatinib.

Criteria

Inclusion Criteria:

  1. Histologic diagnosis of advanced stage or metastatic GIST
  2. Asian patient (as defined by the investigator)
  3. First line treatment with imatinib
  4. Availability of tumor samples for kit mutation analysis
  5. Availability of tumor response rate and or time to progression data

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01227746

Contacts
Contact: Ross Andrew Soo, MBBS 65 6772 4624 Ross_Soo@nuhs.edu.sg

Locations
Singapore
National University Hospital Active, not recruiting
Singapore, Singapore
Sponsors and Collaborators
National University Hospital, Singapore
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT01227746     History of Changes
Other Study ID Numbers: GA03/17/10
Study First Received: October 21, 2010
Last Updated: October 22, 2010
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:
Advanced gastro-intestinal stromal tumors

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on May 16, 2013