Study in Low Risk Gastrointestinal Stromal Tumor (GISTs)

Study Overview
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Brief Summary
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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

Detailed Description
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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

Official Title
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Follow-up in Low Risk Gastrointestinal Stromal Tumors (GISTs) - Retrospective Analysis of Clinical Features and Outcomes

Conditions
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GIST

Intervention / Treatment
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* Other: Treatment of Low Risk GISTs according clinical practice (includes drugs, surgery or any other received treatments)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >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 Exclusion Criteria: Metastases at diagnosis. Previous treatment with imatinib

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Low Risk GISTs<br>This cohort include patients affected by primary GIST at very-low and low risk of recurrence/progression, referred to participating Institutions between January 2000 and February 2020. | Other: Treatment of Low Risk GISTs according clinical practice (includes drugs, surgery or any other received treatments)<br>* This observational study collects all the treatments received by the patients according clinical practices or experimental trials and therefore includes drug/biological/surgical and any other applicable treatments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the most relevant features of follow-up in very-low and low risk GIST patients | Collection of retrospectively imaging characteristics | Change from diagnosis (baseline) | 
| To describe the most relevant features of follow-up in very-low and low risk GIST patients | Collection of retrospectively imaging characteristics. | At 1 year | 
| To describe the most relevant features of follow-up in very-low and low risk GIST patients | Collection of retrospectively imaging characteristics. | At 2 years | 
| To describe the most relevant features of follow-up in very-low and low risk GIST patients | Collection of retrospectively imaging characteristics. | At 3 years | 
| To describe the most relevant features of follow-up in very-low and low risk GIST patients | Collection of retrospectively imaging characteristics. | At 5 years | 
| To evaluate the onset of other neoplasms in very-low and low risk GIST patients | Onset of other neoplasm will be recoreded | Chage from baseline (time of diagnosis) at 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess baseline clinical and disease-specific factors with possible impact on survival analyses. | Collection of clinical symptoms, pathological and molecular characteristics at disease presentation/diagnosis | Every 3 months (Month 3, Month 6, Month 9...) up to 5 years | 
| Recurrence-free survival (RFS) | Time elapsed form the treatment (any) start and the onset of recurrence | Every 3 months (Month 3, Month 6, Month 9...) up to 5 years | 
| Post-recurrence progression-free survival (PR-PFS) | Time elapsed form the onset of 1st progression to a further progression | Every 3 months (Month 3, Month 6, Month 9...) up to 5 years | 
| Disease-Specific survival (DSS) | Time elapsed for the diagnosis to the death of disease | at 5 years | 
| Overall survival (OS). | Time elapsed for the diagnosis to the death for any cause | at 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GIST, Gastro Intestinal Stromal Tumor