Gastrointestinal Stromal Tumors
Conditions
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.
Interventions
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To establish the database for GIST | From date of registration to 31 December 2025 | By register the clinical presentation, diagnostic, stage, treatment and clinical outcome of GIST patients. |
Countries
Taiwan
Contacts
Taiwan Cooperation Organization Group,NHRI,Taiwan