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Observational Registry Data on GIST Patients

Sponsor
National Health Research Institutes, Taiwan (Other)
Overall Status
Recruiting
CT.gov ID
NCT03602092
Collaborator
Taipei Veterans General Hospital, Taiwan (Other), National Taiwan University Hospital (Other), China Medical University Hospital (Other), Changhua Christian Hospital (Other), Chang Gung Memorial Hospital (Other), National Cheng-Kung University Hospital (Other), Kaohsiung Medical University (Other), Taichung Veterans General Hospital (Other)
3,000
Enrollment
1
Location
86.5
Anticipated Duration (Months)
34.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Observation

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
3000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Observational Registry: Nationwide Data Collection on Gastrointestinal Stromal Tumors (GISTs) Patients (Taiwan GISTs Registry)
Actual Study Start Date :
Oct 16, 2018
Anticipated Primary Completion Date :
Dec 31, 2020
Anticipated Study Completion Date :
Dec 31, 2025

Outcome Measures

Primary Outcome Measures

  1. To establish the database for GIST [From date of registration to 31 December 2025]

    By register the clinical presentation, diagnostic, stage, treatment and clinical outcome of GIST patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Yu wei-lan Taipei Taiwan 10048

Sponsors and Collaborators

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

Investigators

  • Study Director: Tsang-Wu Liu, M.D, Taiwan Cooperation Organization Group,NHRI,Taiwan

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT03602092
Other Study ID Numbers:
  • T1218
First Posted:
Jul 26, 2018
Last Update Posted:
Sep 16, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors

Study Results

No Results Posted as of Sep 16, 2020