Clinical trial NCT03602092: Observational Registry Data on GIST Patients
Official title: The Observational Registry: Nationwide Data Collection on Gastrointestinal Stromal Tumors (GISTs) Patients (Taiwan GISTs Registry)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastrointestinal Stromal Tumors
Lead sponsor: National Health Research Institutes, Taiwan
Sponsor class: OTHER
Collaborators: name: Taipei Veterans General Hospital, Taiwan
name: National Taiwan University Hospital
name: China Medical University Hospital
name: Changhua Christian Hospital
name: Chang Gung Memorial Hospital
name: National Cheng-Kung University Hospital
name: Kaohsiung Medical University
name: Taichung Veterans General Hospital
First posted: 2018-07-26
Enrollment: 3000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with Gastrointestinal Stromal Tumor

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.

Eligibility criteria: 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

Primary outcomes:
measure: To establish the database for GIST
timeFrame: From date of registration to 31 December 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Yu wei-lan
Study officials:
affiliation: Taiwan Cooperation Organization Group,NHRI,Taiwan
name: Tsang-Wu Liu, M.D
role: STUDY_DIRECTOR
References: