Observational Registry Data on GIST Patients

May 19, 2025 updated by: National Health Research Institutes, Taiwan

The Observational Registry: Nationwide Data Collection on Gastrointestinal Stromal Tumors (GISTs) Patients (Taiwan GISTs Registry)

This is a longitudinal, multi-center, registry study, collecting data via a web-based portal in patients with GIST (Gastrointestinal Stromal Tumor) from hospitals in Taiwan.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Research question and objectives:

This study is to collect and describe real-world data for Taiwanese GIST on:

  • Prevalence and demographic characteristics of Taiwanese GIST
  • Treatment pattern of GIST therapies
  • Bio-marker and/or gene expression characteristics of Taiwanese GIST
  • Treatment outcome of TKI therapies, including recurrence-free, progression-free and overall survival
  • Safety profile for TKI therapies

Study design: Retrospective and prospective observational cohort study Population: Taiwan GIST patients during 01 January 2010 to 31 December 2020 Data sources: Medical records and investigator-established data bank Study size: Data from up to 3,000 eligible subjects will be collected Data analysis: Descriptive statistics for longitudinally assess nationwide trends on current and evolving diagnostic, treatment, and outcome measures in the GIST population and estimate the prevalence of GIST in Taiwan.

Milestones: Interim report before 31 December 2018 and final study report before 30 June 2026.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Wei-Lan Yu, MSN
  • Phone Number: 67658 886-2-3123456
  • Email: wlyu@nhri.org.tw

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10048
        • Recruiting
        • Yu wei-lan
        • Principal Investigator:
          • Hui-Jen Tsai
        • Contact:
          • Wei-lan Yu, College
          • Phone Number: 67658 +886-2-23123456
          • Email: wlyu@nhri.org.tw

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients diagnosed with Gastrointestinal Stromal Tumor

Description

Inclusion Criteria:

  1. Patients diagnosed with Gastrointestinal Stromal Tumor
  2. ≥20 years old
  3. Histology-confirmed GIST between 01 January 2010 and 31 December 2020.
  4. Patient with prospective data collection: Willing to provide singed inform-consent as per local regulatory requirements.

Exclusion Criteria:

  1. Inability and unwillingness to give informed consent if required by site ethic committee.
  2. Patient that is unlikely candidate to obtain long-term follow-up information for reasons of unavailability or with severe concomitant illnesses per investigator judgement

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To establish the database for GIST
Time Frame: From date of registration to 31 December 2025
By register the clinical presentation, diagnostic, stage, treatment and clinical outcome of GIST patients.
From date of registration to 31 December 2025

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Health Research Institutes, Taiwan

Collaborators

National Taiwan University Hospital
China Medical University Hospital
Chang Gung Memorial Hospital
Taipei Veterans General Hospital, Taiwan
National Cheng-Kung University Hospital
Kaohsiung Medical University
Changhua Christian Hospital
Taichung Veterans General Hospital

Investigators

  • Study Director: Tsang-Wu Liu, M.D, Taiwan Cooperation Organization Group,NHRI,Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2018

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

July 16, 2018

First Submitted That Met QC Criteria

July 25, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

May 22, 2025

Last Update Submitted That Met QC Criteria

May 19, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T1218

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

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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