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Status unknownNCT03381053Updated Dec 21, 2017

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

An observational study in Method of Differentiating Benignancy and Malignancy, Grading and Staging for GIST, sponsored by Shanghai Zhongshan Hospital. Status unknown at 1 site in China. Open to participants aged 14 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-12-21.

Sponsored by Shanghai Zhongshan Hospital · Observational

The sponsor has not verified this record recently (last verified Dec 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Ages
14 Years to 80 Years
Sex
All
01

Study 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

Read the 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.
02

Conditions studied

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

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Keywords

  • GIST
  • Grading and Staging
03

In context

Neoplasms

9,610 studies on the registry are indexed under Neoplasms; 2,508 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 202 across 1,742 observational studies indexed under Neoplasms.

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Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 648 studies on the registry; 289 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with GIST by pathology

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Only have Biopsy diagnosis
  • Only have Liver metastasis or peritoneal dissemination
  • Received imatinib treatment before surgery
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

    Drug: Imatinib 400mg

  • 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.

Interventions

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

06

What researchers measure

Primary outcomes

  1. Number of participants with tumor recurrence

    Time frame: 3 years

  2. Number of participants with tumor metastasis

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • 180 Fenglin Road
    Shanghai, Shanghai Municipality 200032, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03381053
Responsible party
Sponsor
First posted
Dec 21, 2017
Start date
Jul 1, 2017
Primary completion
Jul 1, 2020 (estimated)
Completion
Jan 1, 2022 (estimated)
Last update
Dec 21, 2017

Study contacts

Hou Ying Yong, Doctor
Contact
Hou.yingyong@zs-hospital.sh.cn
13681972385 ext. 86
Yuan wei, master
Contact
yuan.wei@zs-hospital.sh.cn
15001871484 ext. 86
Hou Ying Yong, Doctor
study chair · Shanghai Zhongshan Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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