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Status unknownNCT02353052Updated Feb 2, 2015

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

An observational study in Gastrointestinal Stromal Tumor, sponsored by Shanghai Zhongshan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-02-02.

Sponsored by Shanghai Zhongshan Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2015), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
900
Ages
18 Years to 80 Years
Sex
All
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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 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.
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Conditions studied

  • Gastrointestinal Stromal Tumor

Keywords

  • morphology standards
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In context

Gastrointestinal Stromal Tumors

333 studies on the registry are indexed under Gastrointestinal Stromal Tumors; 61 are open to participants now.

This study's planned enrollment of 900 is above the median of 116 across 68 observational studies indexed under Gastrointestinal Stromal Tumors.

Browse Gastrointestinal Stromal Tumors studies →

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.

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

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Who can participate

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

Study population

patients diagnosed with GIST by pathology

Eligibility criteria

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

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
900 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

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.

    Other: follow up

  • 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.

    Other: follow up

Interventions

  • Otherfollow up

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

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 200032, China
    • Yingyong Hou, doctor · Contact · hou.yingyong@zs-hospital.sh.cn · 86-13681972385
    • Yingyong Hou, doctor · Principal investigator
    • Xin Zhang, doctor · Sub investigator
    • Rongkui Luo, master · Sub investigator
    • Wei Yuan, master · Sub investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02353052
Lead sponsor
Shanghai Zhongshan Hospital
Responsible party
Sponsor
First posted
Feb 2, 2015
Start date
Jul 2013
Primary completion
Sep 2016 (estimated)
Last update
Feb 2, 2015

Study contacts

Yingyong Hou, Doctor
Contact
hou.yingyong@zs-hospital.sh.cn
Yingyong Hou, Doctor
study chair · Shanghai Zhongshan Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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