Study in Low Risk Gastrointestinal Stromal Tumor (GISTs)

NCT ID: NCT04599660

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-11-25
• Study Completion Date: 2023-12-20

Brief Summary

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

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

Conditions

GIST

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Low Risk GISTs

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

Intervention Type: OTHER

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

Interventions

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

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Italian Sarcoma Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Giovanni Grignani

Role: STUDY_CHAIR

giovanni.grignani@ircc.it

Locations

Azienda Ospedaliero-Universitaria Di Bologna

Bologna, BO, Italy

Nuovo Ospedale di Prato

Prato, Firenze, Italy

Istituto Europeo di Oncologia

Milan, MI, Italy

Istituto Clinico Humanitas

Rozzano, MI, Italy

Azienda Ospedaliera Universitaria Paolo Giaccone

Palermo, PA, Italy

Centro di Riferimento Oncologico - Unit of Medical Oncology

Aviano, Pordenone, Italy

Policlinico Universitario Campus Biomedico

Roma, RM, Italy

Fondazione del Piemonte per l'Oncologia IRCC Candiolo

Candiolo, Torino, Italy

Ospedale San Giovanni Bosco

Torino, TO, Italy

Policlinico S.Orsola Malpighi - Unit of Medical Oncology

Bologna, , Italy

Azienda Ospedaliera Universitaria Careggi

Florence, , Italy

Fondazione IRCCS INT Milano

Milan, , Italy

Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I

Roma, , Italy

Countries

Italy

References

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Other Identifiers

ISG-RetroGIST LR

Identifier Type: -

Identifier Source: org_study_id