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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.
Conditions
Asian Patients With Advanced Gastro-intestinal Stromal Tumors (GIST) Treated With Imatinib
Conditions: official terms
Gastrointestinal Stromal Tumors
Conditions: Keywords
Advanced gastro-intestinal stromal tumors
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Retrospective
Intervention
Name: Tumor biopsies
Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 21 Years
Gender: Both
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:
-
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:
-
Location
National University Hospital
Singapore, Singapore
Status: Recruiting
Contact: Ross Andrew Soo , MBBS - 65 6772 4624 - Ross_Soo@nuhs.edu.sg
Start Date
September 2011
Completion Date
December 2014
Sponsors
National University Hospital, Singapore
Source
National University Hospital, Singapore
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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