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

NCT01227746 | Unknown

• 1 other identifier: GA03/17/10
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Asian Patients With Advanced Gastro-intestinal Stromal Tumors (GIST) Treated With Imatinib

Keywords

Advanced gastro-intestinal stromal tumors

Study Arms (1)

Tumor biopsies

Procedure: Tumor biopsies

Interventions

Tumor biopsies PROCEDURE

Tumor biopsies

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore, Singapore

RECRUITING

Related Publications (2)

• Tornillo L, Terracciano LM. An update on molecular genetics of gastrointestinal stromal tumours. J Clin Pathol. 2006 Jun;59(6):557-63. doi: 10.1136/jcp.2005.031112.

  PMID: 16731599 BACKGROUND

• Heinrich MC, Corless CL, Duensing A, McGreevey L, Chen CJ, Joseph N, Singer S, Griffith DJ, Haley A, Town A, Demetri GD, Fletcher CD, Fletcher JA. PDGFRA activating mutations in gastrointestinal stromal tumors. Science. 2003 Jan 31;299(5607):708-10. doi: 10.1126/science.1079666. Epub 2003 Jan 9.

  PMID: 12522257 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Central Study Contacts

Ross Andrew Soo, MBBS

CONTACT

65 6772 4624; Ross_Soo@nuhs.edu.sg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 21, 2010
• First Posted: October 25, 2010
• Study Start: September 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 22, 2014

Record last verified: 2014-01

Locations

SG (1)