Observational Registry Data on GIST Patients

NCT ID: NCT03602092

Last Updated: 2025-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-10-16

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Gastrointestinal Stromal Tumors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role collaborator

China Medical University Hospital

OTHER

Sponsor Role collaborator

Changhua Christian Hospital

OTHER

Sponsor Role collaborator

Chang Gung Memorial Hospital

OTHER

Sponsor Role collaborator

National Cheng-Kung University Hospital

OTHER

Sponsor Role collaborator

Kaohsiung Medical University

OTHER

Sponsor Role collaborator

Taichung Veterans General Hospital

OTHER

Sponsor Role collaborator

National Health Research Institutes, Taiwan

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tsang-Wu Liu, M.D

Role: STUDY_DIRECTOR

Taiwan Cooperation Organization Group,NHRI,Taiwan

Locations

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Yu wei-lan

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Hui-Jen Tsai, M.D

Role: CONTACT

886-06-2083427 ext. 65149

Wei-Lan Yu, MSN

Role: CONTACT

886-2-3123456 ext. 67658

Facility Contacts

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Wei-lan Yu, College

Role: primary

+886-2-23123456 ext. 67658

Other Identifiers

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T1218

Identifier Type: -

Identifier Source: org_study_id

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