The Observational Registry: Nationwide Data Collection on Gastrointestinal Stromal Tumors (GISTs) Patients (Taiwan GISTs Registry)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Gastrointestinal Stromal Tumors
- Sponsor
- National Health Research Institutes, Taiwan
- Enrollment
- 3000
- Locations
- 1
- Primary Endpoint
- To establish the database for GIST
- Status
- Recruiting
- Last Updated
- 11 months ago
Overview
Brief 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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients diagnosed with Gastrointestinal Stromal Tumor
- •≥20 years old
- •Histology-confirmed GIST between 01 January 2010 and 31 December
- •Patient with prospective data collection: Willing to provide singed inform-consent as per local regulatory requirements.
Exclusion Criteria
- •Inability and unwillingness to give informed consent if required by site ethic committee.
- •Patient that is unlikely candidate to obtain long-term follow-up information for reasons of unavailability or with severe concomitant illnesses per investigator judgement
Outcomes
Primary Outcomes
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.