The Observational Registry: Nationwide Data Collection on Gastrointestinal Stromal Tumors (GISTs) Patients (Taiwan GISTs Registry)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 966
- 试验地点
- 2
- 主要终点
- To establish the database for GIST
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with Gastrointestinal Stromal Tumor
- •≥20 years old
- •Histology-confirmed GIST between 01 January 2010 and 31 December
- •Patient with prospective data collection: Willing to provide singed inform-consent as per local regulatory requirements.
排除标准
- •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
结局指标
主要结局
To establish the database for GIST
时间窗: From date of registration to 31 December 2025
By register the clinical presentation, diagnostic, stage, treatment and clinical outcome of GIST patients.
次要结局
未报告次要终点