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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03381053
Enrollment
3000
Registered
2017-12-21
Start date
2017-07-01
Completion date
2022-01-01
Last updated
2017-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Method of Differentiating Benignancy and Malignancy, Grading and Staging for GIST

Keywords

GIST, Grading and Staging

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.

Interventions

The NIH assessment of patients with surgical excision of GIST with moderate to high risk of recurrence was recommended imatinib 400mg treatment.

Sponsors

Ruijin Hospital
CollaboratorOTHER
Fudan University
CollaboratorOTHER
Changhai Hospital
CollaboratorOTHER
Shanghai Changzheng Hospital
CollaboratorOTHER
Huashan Hospital
CollaboratorOTHER
Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
14 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of participants with tumor recurrence3 years
Number of participants with tumor metastasis3 years

Countries

China

Contacts

Primary ContactHou Ying Yong, Doctor
Hou.yingyong@zs-hospital.sh.cn13681972385
Backup ContactYuan wei, master
yuan.wei@zs-hospital.sh.cn15001871484

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026