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

NCT ID: NCT02353052

Last Updated: 2015-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 900 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-07-31

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.

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.

Conditions

Gastrointestinal Stromal Tumor

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

follow up

Intervention Type: OTHER

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

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.

follow up

Intervention Type: OTHER

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

Interventions

follow up

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yingyong Hou, Doctor

Role: STUDY_CHAIR

Shanghai Zhongshan Hospital

Locations

180 Fenglin Road

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yingyong Hou, Doctor

Role: CONTACT

hou.yingyong@zs-hospital.sh.cn

Facility Contacts

Yingyong Hou, doctor

Role: primary

hou.yingyong@zs-hospital.sh.cn

86-13681972385

Other Identifiers

ShanghaiZhongshan

Identifier Type: -

Identifier Source: org_study_id