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

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

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

Study Overview

• Status: Unknown
• Conditions: Method of Differentiating Benignancy and Malignancy, Grading and Staging for GIST
• Intervention / Treatment: Drug: Imatinib 400mg

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.

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • 180 Fenglin Road
      • Contact: Hou Ying yong, doctor; Phone Number: 86 13681972385; Email: You.yingyong@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with GIST by pathology

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; The NIH assessment of patients with surgical excision of GIST with moderate to high risk of recurrence was recommended imatinib 400mg treatment.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with tumor recurrence	3 years
Number of participants with tumor metastasis	3 years

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Changhai Hospital; Fudan University; Huashan Hospital; Ruijin Hospital; Shanghai Changzheng Hospital
• Investigators: Study Chair: Hou Ying Yong, Doctor, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2017
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: December 18, 2017
• First Submitted That Met QC Criteria: December 20, 2017
• First Posted (Actual): December 21, 2017

Study Record Updates

• Last Update Posted (Actual): December 21, 2017
• Last Update Submitted That Met QC Criteria: December 20, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: GIST; Grading and Staging
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Neoplasms, Connective Tissue; Neoplasms; Gastrointestinal Stromal Tumors; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Imatinib Mesylate
• Other Study ID Numbers: SH-GIST2017pathology

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No