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

NCT ID: NCT01227746

Last Updated: 2014-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Tumor biopsies

Tumor biopsies

Intervention Type PROCEDURE

Interventions

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Tumor biopsies

Intervention Type PROCEDURE

Eligibility Criteria

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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

\-
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National University Hospital, Singapore

OTHER

Sponsor Role lead

Locations

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National University Hospital

Singapore, Singapore, Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Ross Andrew Soo, MBBS

Role: CONTACT

65 6772 4624

Facility Contacts

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Ross Andrew Soo, MBBS

Role: primary

65 6772 4624

References

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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.

Reference Type BACKGROUND
PMID: 16731599 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12522257 (View on PubMed)

Other Identifiers

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GA03/17/10

Identifier Type: -

Identifier Source: org_study_id

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