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

NCT03381053 | Unknown DMC FDA Drug

• 1 other identifier: SH-GIST2017pathology
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

GIST; Grading and Staging

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.

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

Imatinib 400mg DRUG

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

Treatment observation group

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with GIST by pathology

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Ruijin Hospital: collaborator
• Fudan University: collaborator
• Changhai Hospital: collaborator
• Shanghai Changzheng Hospital: collaborator
• Huashan Hospital: collaborator

Study Sites (1)

180 Fenglin Road

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Imatinib Mesylate

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Hou Ying Yong, Doctor

  Shanghai Zhongshan Hospital

  STUDY CHAIR

Central Study Contacts

Hou Ying Yong, Doctor

CONTACT

13681972385; Hou.yingyong@zs-hospital.sh.cn

Yuan wei, master

CONTACT

15001871484; yuan.wei@zs-hospital.sh.cn

Study Design

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

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: December 21, 2017
• Study Start: July 1, 2017
• Primary Completion: July 1, 2020
• Study Completion: January 1, 2022
• Last Updated: December 21, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)