Observational Registry Data on GIST Patients

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: Gastrointestinal Stromal Tumors
• Intervention / Treatment: Other: Observation

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

• Study Contact: Name: Hui-Jen Tsai, M.D; Phone Number: 65149 886-06-2083427; Email: hjtsai@nhri.org.tw
• 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

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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To establish the database for GIST	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

• 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

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 (Estimated): November 9, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Neoplasms, Connective Tissue; Gastrointestinal Stromal Tumors
• 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