Study in Low Risk Gastrointestinal Stromal Tumor (GISTs)

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

Sponsors

Lead Sponsor: Italian Sarcoma Group

Source Italian Sarcoma Group
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

Overall Status Not yet recruiting
Start Date December 15, 2020
Completion Date March 15, 2021
Primary Completion Date March 15, 2021
Study Type Observational
Primary Outcome
Measure Time Frame
To describe the most relevant features of follow-up in very-low and low risk GIST patients Change from diagnosis (baseline)
To describe the most relevant features of follow-up in very-low and low risk GIST patients At 1 year
To describe the most relevant features of follow-up in very-low and low risk GIST patients At 2 years
To describe the most relevant features of follow-up in very-low and low risk GIST patients At 3 years
To describe the most relevant features of follow-up in very-low and low risk GIST patients At 5 years
To evaluate the onset of other neoplasms in very-low and low risk GIST patients Chage from baseline (time of diagnosis) at 5 years
Secondary Outcome
Measure Time Frame
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
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
Overall survival (OS). at 5 years
Enrollment 700
Condition
Intervention

Intervention Type: Other

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

Description: 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

Arm Group Label: Low Risk GISTs

Eligibility

Sampling Method: Non-Probability Sample

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

Gender: All

Minimum Age: 19 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Giovanni Grignani Study Chair [email protected]
Overall Contact

Last Name: Giovanni Grignani, MD

Phone: +39 (011) 9933623

Email: [email protected]

Location
Facility: Contact: Investigator:
Azienda Ospedaliero-Universitaria Di Bologna | Bologna, BO, 40139, Italy Maria Abbondanza Pantaleo, MD +39051214 4078 [email protected] Maria Abbondanza Maria Abbondanza, MD Principal Investigator
Nuovo Ospedale di Prato | Prato, Firenze, 59100, Italy Giacomo G. Baldi, MD 0039057443 4766 [email protected] Giacomo G. Baldi, MD Principal Investigator
Istituto Europeo di Oncologia | Milano, MI, 20141, Italy
Istituto Clinico Humanitas | Rozzano, MI, 20089, Italy Alexia Bertuzzi, MD +390282244540 [email protected] Alexia Bertuzzi, MD Principal Investigator
Azienda Ospedaliera Universitaria Paolo Giaccone | Palermo, PA, 90127, Italy Giuseppe Badalamenti, MD 0039091655 4513 [email protected] Giuseppe Badalamenti, MD Principal Investigator
Centro di Riferimento Oncologico - Unit of Medical Oncology | Aviano, Pordenone, 33081, Italy
Policlinico Universitario Campus Biomedico | Roma, RM, 00128, Italy Bruno Vincenzi, MD +3902225411123 [email protected] Bruno Vincenzi, MD Principal Investigator
Fondazione del Piemonte per l'Oncologia IRCC Candiolo | Candiolo, Torino, 10060, Italy Giovanni Grignani, MD 39 (011) 993 3623 [email protected] Giovanni Grignani, MD Principal Investigator
Ospedale San Giovanni Bosco | Torino, TO, Italy Alessandro Comandone, MD Alessandro Comandone, MD Principal Investigator
Policlinico S.Orsola Malpighi - Unit of Medical Oncology | Bologna, 40138, Italy
Azienda Ospedaliera Universitaria Careggi | Firenze, 50100, Italy Silvia Gasperoni, MD 39 055 7949648 [email protected] Silvia Gasperoni, MD Principal Investigator
Fondazione IRCCS INT Milano | Milano, 20133, Italy Elena Fumagali, MD +39022390 2804 [email protected] Elena Fumagali, MD Principal Investigator
Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I | Roma, 00144, Italy
Location Countries

Italy

Verification Date

October 2020

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: 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.

Acronym RetroGIST
Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Retrospective

Source: ClinicalTrials.gov