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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.

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ClinicalTrials.gov Identifier: NCT01227746
Recruitment Status : Unknown
Verified January 2014 by National University Hospital, Singapore.
Recruitment status was:  Recruiting
First Posted : October 25, 2010
Last Update Posted : January 22, 2014
Sponsor:
Information provided by:
National University Hospital, Singapore

Brief Summary:
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 or disease Intervention/treatment
Asian Patients With Advanced Gastro-intestinal Stromal Tumors (GIST) Treated With Imatinib Procedure: Tumor biopsies

Study Type : Observational
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : September 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014


Group/Cohort Intervention/treatment
Tumor biopsies Procedure: Tumor biopsies




Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01227746


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

Locations
Singapore
National University Hospital Recruiting
Singapore, Singapore
Contact: Ross Andrew Soo , MBBS    65 6772 4624    Ross_Soo@nuhs.edu.sg   
Principal Investigator: Ross Andrew Soo, MBBS         
Sponsors and Collaborators
National University Hospital, Singapore

Publications:
ClinicalTrials.gov Identifier: NCT01227746     History of Changes
Other Study ID Numbers: GA03/17/10
First Posted: October 25, 2010    Key Record Dates
Last Update Posted: January 22, 2014
Last Verified: January 2014

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

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases