NCT02353052

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

January 17, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 2, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Last Updated

February 2, 2015

Status Verified

January 1, 2015

Enrollment Period

3.2 years

First QC Date

January 17, 2015

Last Update Submit

January 28, 2015

Conditions

Keywords

morphology standards

Outcome Measures

Primary Outcomes (2)

  • Number of participants with tumor recurrence

    3 years

  • Number of participants with tumor metastasis

    3 years

Study Arms (2)

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

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

Control observation groupTreatment observation group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients diagnosed with GIST by pathology

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

180 Fenglin Road

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

GIST paraffin specimens

MeSH Terms

Conditions

Gastrointestinal Stromal Tumors

Condition Hierarchy (Ancestors)

Neoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • Yingyong Hou, Doctor

    Shanghai Zhongshan Hospital

    STUDY CHAIR

Central Study Contacts

Yingyong Hou, Doctor

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2015

First Posted

February 2, 2015

Study Start

July 1, 2013

Primary Completion

September 1, 2016

Last Updated

February 2, 2015

Record last verified: 2015-01

Locations