Observational Registry Data on GIST Patients

National Health Research Institutes, Taiwan

Status: Enrolling

Conditions: Gastrointestinal Stromal Tumors

Treatments: Other: Observation

Study type: Observational

Funder types: Other

Identifiers

NCT03602092

T1218

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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