Observational Registry Data on GIST Patients

Gastrointestinal Stromal Tumors Clinical Trial

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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

• NCT number: NCT03602092
• Study type: Observational [Patient Registry]
• Source: National Health Research Institutes, Taiwan
• Contact: Hui-Jen Tsai, M.D
• Phone: 886-06-2083427
• Email: hjtsai@nhri.org.tw
• Status: Recruiting
• Start date: October 16, 2018
• Completion date: December 31, 2025