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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. ;


Study Design


Related Conditions & MeSH terms


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
Phase
Start date October 16, 2018
Completion date December 31, 2025

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