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Prospective Cohort Study of the Clinical Applications for the Pathologic Type, Staging, and Grading of GIST

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02353052
Enrollment
900
Registered
2015-02-02
Start date
2013-07-31
Completion date
Unknown
Last updated
2015-02-02

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

Conditions

Gastrointestinal Stromal Tumor

Keywords

morphology standards

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 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

OTHERfollow up

The patients were followed up for 3 years about their survival conditions and tumor status (eg. recurrence and metastasis).

Sponsors

Shanghai Zhongshan Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

All patients pathologically diagnosed with GIST during the period from 2013 to 2015

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactYingyong Hou, Doctor
hou.yingyong@zs-hospital.sh.cn

Outcome results

None listed

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