Study to Compare Pathologic Type, NIH and WHO Criteria,and Mechanism of GIST Malignant Transformation

• Conditions: Method of Differentiating Benignancy and Malignancy, Grading and Staging for GIST
• Interventions: Drug: Imatinib 400mg

• Registration Number: NCT03381053
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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

Detailed Description

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 multicenter 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.

Study Timeline

• Study Start: 2017-07-01
• Status Verified: 2017-12
• Study First Submitted: 2017-12-18
• Study First Submitted QC: 2017-12-20
• Last Update Submitted: 2017-12-20
• Study First Posted: 2017-12-21
• Last Update Posted: 2017-12-21
• Primary Completion: 2020-07-01
• Study Completion: 2022-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• All patients pathologically diagnosed with GIST during the period from 2017 to 2020

Exclusion Criteria

• Only have Biopsy diagnosis
• Only have Liver metastasis or peritoneal dissemination
• Received imatinib treatment before surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment observation group	Imatinib 400mg	According to the morphological criteria, the NIH scheme, and the WHO standard, GIST patients are divided into two groups, benign group and malignant group. In fully informed of their illness, patients are free to choose the sequence treatments according to their own gene mutation status and economic conditions. Patients who choose postoperative Imatinib treatment are labeled treatment group.

Primary Outcome Measures

Name	Time	Method
Number of participants with tumor recurrence	3 years
Number of participants with tumor metastasis	3 years

Trial Locations

Locations (1)

180 Fenglin Road; 🇨🇳 Shanghai, Shanghai, China