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.

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.

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