Follow-up in Low Risk Gastrointestinal Stromal Tumors (GISTs) - Retrospective Analysis of Clinical Features and Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 700
- 试验地点
- 13
- 主要终点
- To evaluate the onset of other neoplasms in very-low and low risk GIST patients
研究概览
简要总结
This is a multi-institutional retrospective study in order to identify the most relevant and advisable features of follow-up, and to explore its impact on principal clinical outcomes. Moreover, a dedicated effort will be pursued to identify the peculiar characteristics (if any) of patients that experienced recurrence of the disease.
The study will collect data about patients affected by primary GIST at very-low and low risk of recurrence/progression, referred to participating Institutions between January 2000 and February 2020
详细描述
In the field of soft tissue sarcomas, Gastrointestinal Stromal Tumors (GIST) represents a really peculiar neoplasm for its biological and clinical properties. Surgery (if feasible) is the main therapeutic approach for all the patients with localized disease, while a pharmacological adjuvant treatment is reserved to those with a relevant risk of recurrence/progression.
After tumor removal, clinical and radiological follow-up is of central importance to early intercept recurrence and to evaluate the most correct subsequent therapeutic approach. In particular, for the group of patients with GIST at very-low and low risk of recurrence/progression, the evidences to support a specific follow-up program and its features are poor.
On the basis of the aforementioned considerations, we propose a multi-institutional retrospective study in order to identify the most relevant and advisable features of follow-up, and to explore its impact on principal clinical outcomes. Moreover, a dedicated effort will be pursued to identify the peculiar characteristics (if any) of patients that experienced recurrence of the disease.
The study will collect data about patients affected by primary GIST at very-low and low risk of recurrence/progression, referred to participating Institutions between January 2000 and February 2020
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years at diagnosis
- •primary GIST removed by surgery or endoscopic procedures
- •availability of medical data needed for the study
- •very-low and low risk GIST defined as:
- •largest size of < 3 cm (for all sites of origin)
- •gastric GIST with ≤ 5/50 High Power Fields (HPF) mitoses and ≤ 10 cm in the largest size
- •gastric GIST with > 5/50 HPF mitoses and ≤ 5 cm in the largest size
- •intestinal GIST with ≤ 5/50 HPF mitoses and ≤ 5 cm in the largest size
排除标准
- •Metastases at diagnosis.
- •Previous treatment with imatinib
结局指标
主要结局
To evaluate the onset of other neoplasms in very-low and low risk GIST patients
时间窗: Chage from baseline (time of diagnosis) at 5 years
Onset of other neoplasm will be recoreded
To describe the most relevant features of follow-up in very-low and low risk GIST patients
时间窗: At 5 years
Collection of retrospectively imaging characteristics.
次要结局
- To assess baseline clinical and disease-specific factors with possible impact on survival analyses.(Every 3 months (Month 3, Month 6, Month 9...) up to 5 years)
- Recurrence-free survival (RFS)(Every 3 months (Month 3, Month 6, Month 9...) up to 5 years)
- Overall survival (OS).(at 5 years)
- Post-recurrence progression-free survival (PR-PFS)(Every 3 months (Month 3, Month 6, Month 9...) up to 5 years)
- Disease-Specific survival (DSS)(at 5 years)