Study on the Evolution of Genes Mutation Related With Gastrointestinal Stromal Tumors
| Tracking Information | |
|---|---|
| First Received Date ICMJE | January 4, 2012 |
| Last Updated Date | January 5, 2012 |
| Start Date ICMJE | April 2011 |
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT01505205 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Study on the Evolution of Genes Mutation Related With Gastrointestinal Stromal Tumors |
| Official Title ICMJE | Not Provided |
| Brief Summary | Mutations of tumor-related genes are dynamic. Gastrointestinal stromal tumor cells often are obviously more invasive in case of recurrence. The great majority of relapses may be associated with secondary mutation in the GIST related genes. Full gene sequences of c-KIT、PDGFRA and DOG1, which is extracted from the specimen cells of repeated surgical resection or biopsy tissue in GIST patients with postoperative recurrence, are analyzed with the screening-sequencing approach, in order to investigate the characteristics and variations associated with the different gene mutations of c-KIT、PDGFRA and DOG1 in GIST patients and be likely to find out the evolutionary pattern, try to learn the facts about the effect of tyrosine kinase inhibitors on the GIST related genes, make a survey of any association of c-KIT、PDGFRA and DOG1 gene mutations and provide the basis for seeking molecular marker of GIST for monitoring course of disease, and offer a theoretical basis and new therapeutic strategies for application of clinical treatment. |
| Detailed Description | Not Provided |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Probability Sample |
| Study Population | patients with Gist at the Department of Gastrointestinal and Glands Surgery of the First Affiliated Hospital of Guangxi Medical University in China. |
| Condition ICMJE |
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| Intervention ICMJE | Not Provided |
| Study Group/Cohort (s) | Not Provided |
| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 60 |
| Completion Date | June 2011 |
| Primary Completion Date | May 2011 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | Not Provided |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Not Provided |
| Administrative Information | |
| NCT Number ICMJE | NCT01505205 |
| Other Study ID Numbers ICMJE | H1606-81160274 |
| Has Data Monitoring Committee | Yes |
| Responsible Party | Zhang Haitian, Guangxi Medical University |
| Study Sponsor ICMJE | Guangxi Medical University |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Guangxi Medical University |
| Verification Date | January 2012 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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