Observational Registry Data on GIST Patients

Gastrointestinal Stromal Tumors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03602092
• Other study ID #: T1218
• Status: Recruiting
• Start date: October 16, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: National Health Research Institutes, Taiwan
• Contact: Hui-Jen Tsai, M.D
• Phone: 886-06-2083427
• Email: hjtsai[@]nhri.org.tw
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Yu wei-lan	Taipei

Sponsors (9)

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

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish the database for GIST	By register the clinical presentation, diagnostic, stage, treatment and clinical outcome of GIST patients.	From date of registration to 31 December 2025