Study in Low Risk Gastrointestinal Stromal Tumor (GISTs) (RetroGIST)

Italian Sarcoma Group

Status: Completed

Conditions: GIST

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

Study type: Observational

Funder types: NETWORK

Identifiers

NCT04599660

ISG-RetroGIST LR

Details and patient eligibility

About

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

Full description

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

Enrollment: 700 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

700 participants in 1 patient group

Low Risk GISTs

Description:

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.

Treatment:

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