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Observational Registry Data on GIST Patients

The Observational Registry: Nationwide Data Collection on Gastrointestinal Stromal Tumors (GISTs) Patients (Taiwan GISTs Registry)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03602092
Enrollment
966
Registered
2018-07-26
Start date
2018-10-16
Completion date
2025-12-31
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Stromal Tumors

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

OTHERObservation

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

National Health Research Institutes, Taiwan
Lead SponsorOTHER
Taipei Veterans General Hospital, Taiwan
CollaboratorOTHER_GOV
National Taiwan University Hospital
CollaboratorOTHER
China Medical University Hospital
CollaboratorOTHER
Changhua Christian Hospital
CollaboratorOTHER
Chang Gung Memorial Hospital
CollaboratorOTHER
National Cheng-Kung University Hospital
CollaboratorOTHER
Kaohsiung Medical University
CollaboratorOTHER
Taichung Veterans General Hospital
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
To establish the database for GISTFrom date of registration to 31 December 2025By register the clinical presentation, diagnostic, stage, treatment and clinical outcome of GIST patients.

Countries

Taiwan

Contacts

STUDY_DIRECTORTsang-Wu Liu, M.D

Taiwan Cooperation Organization Group,NHRI,Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026