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Recruiting NCT03602092

Observational Registry Data on GIST Patients

— Observational Gastrointestinal Stromal Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observation.
Who it may be relevant to
Registry conditions: Gastrointestinal Stromal Tumors. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Other Observation
    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.

Primary outcome measures

  • To establish the database for GIST [Time frame: From date of registration to 31 December 2025]

Eligibility criteria

Inclusion criteria

  • Patients diagnosed with Gastrointestinal Stromal Tumor
  • ≥20 years old
  • Histology-confirmed GIST between 01 January 2010 and 31 December 2020.
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Taiwan · 1 center
  • Yu wei-lan — Taipei

Identifiers

NCT: NCT03602092 · T1218

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗