Study to Compare Pathologic Type, NIH and WHO Criteria,and Mechanism of GIST Malignant Transformation
NCT ID: NCT03381053
Last Updated: 2017-12-21
Study Results
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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UNKNOWN
3000 participants
OBSERVATIONAL
2017-07-01
2022-01-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Treatment observation group
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.
Imatinib 400mg
The NIH assessment of patients with surgical excision of GIST with moderate to high risk of recurrence was recommended imatinib 400mg treatment.
Control observation group
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 no Imatinib treatment are labeled observation group.
No interventions assigned to this group
Interventions
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Imatinib 400mg
The NIH assessment of patients with surgical excision of GIST with moderate to high risk of recurrence was recommended imatinib 400mg treatment.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Only have Liver metastasis or peritoneal dissemination
* Received imatinib treatment before surgery
14 Years
80 Years
ALL
No
Sponsors
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Ruijin Hospital
OTHER
Fudan University
OTHER
Changhai Hospital
OTHER
Shanghai Changzheng Hospital
OTHER
Huashan Hospital
OTHER
Shanghai Zhongshan Hospital
OTHER
Responsible Party
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Principal Investigators
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Hou Ying Yong, Doctor
Role: STUDY_CHAIR
Shanghai Zhongshan Hospital
Locations
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180 Fenglin Road
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Hou Ying yong, doctor
Role: primary
Other Identifiers
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SH-GIST2017pathology
Identifier Type: -
Identifier Source: org_study_id