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Trial Title:
A Retrospective Study of C-kit Mutation Status in Asian Patients With Advanced Gastro-intestinal Stromal Tumors (GIST) Treated With Imatinib.
NCT ID:
NCT01227746
Condition:
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
Overall status:
Unknown status
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Procedure
Intervention name:
Tumor biopsies
Arm group label:
Tumor biopsies
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:
Study pop:
Asian patients with advanced gastro-intestinal stromal tumors (GIST) treated with
imatinib.
Sampling method:
Non-Probability Sample
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:
-
Gender:
All
Minimum age:
21 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
National University Hospital
Address:
City:
Singapore
Country:
Singapore
Status:
Recruiting
Contact:
Last name:
Ross Andrew Soo, MBBS
Phone:
65 6772 4624
Email:
Ross_Soo@nuhs.edu.sg
Investigator:
Last name:
Ross Andrew Soo, MBBS
Email:
Principal Investigator
Start date:
September 2011
Completion date:
December 2014
Lead sponsor:
Agency:
National University Hospital, Singapore
Agency class:
Other
Source:
National University Hospital, Singapore
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01227746
