Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2025-12-27 @ 5:04 PM
Study NCT ID:
NCT03602092
Status:
RECRUITING
Last Update Posted:
2025-05-22
First Post:
2018-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Registry Data on GIST Patients
Sponsor:
National Health Research Institutes, Taiwan
Organization:
Study Overview
Official Title:
The Observational Registry: Nationwide Data Collection on Gastrointestinal Stromal Tumors (GISTs) Patients (Taiwan GISTs Registry)
Status:
RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: