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临床试验/NCT02353052
NCT02353052Unknown不适用

Prospective Cohort Study of the Clinical Applications for the Pathologic Type, Staging, and Grading of Primary Gastrointestinal Stromal Tumor

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2013年7月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
900
试验地点
1
主要终点
Number of participants with tumor recurrence

研究概览

简要总结

Evaluate the reliability of morphology standards for GIST pathologic type, staging and grading by retrospective analyzing clinical data; on this basis, establish a GIST standardized and individualized treatment mode to maximum benefit GIST patients, avoid under- and over-treatment.

详细描述

  1. Retrospective analysis of GIST cases in the recent five years: the GIST clinical data of Fudan University Zhongshan Hospital from 2007 January to 2012 December were collected. By reviewing the HE slides, GIST was evaluated by 12 indicators, NIH scheme and WHO standard. Accomplish the gene sequencing of KIT, PDGFRA, B-raf, and SDH. Follow up the patients about their treatment and prognosis. Analyze and compare the advantages and disadvantages of the histomorphology indicators, NIH scheme, and WHO standard.
  2. Organize the first prospective cohort study of GIST individualized treatment based on the histomorphology. Obtain the evidence of histological assessment for GIST by following up patients for 3 years.
  3. Establish an evaluation criteria based on the morphology of GIST. Make objective evaluations about GIST tumor size, tumor location and gene mutation status in the prognosis estimate. Make rules to effectively guide individualized treatment of GIST.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Number of participants with tumor recurrence

时间窗: 3 years

Number of participants with tumor metastasis

时间窗: 3 years

次要结局

未报告次要终点

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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