Study in Low Risk Gastrointestinal Stromal Tumor (GISTs)

NCT04599660 | Completed

• 1 other identifier: ISG-RetroGIST LR
• Study Type: observational
• Target: 700
• Locations: 1 country
• Sites: 13

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

Conditions

GIST

Keywords

GIST; Gastro Intestinal Stromal Tumor

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (5)

• 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

Study Arms (1)

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.

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

Interventions

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

Low Risk GISTs

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients affected by primary GIST at very-low and low risk of recurrence/progression, referred to participating Institutions between January 2000 and February 2020.

You may qualify if:

• \>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

You may not qualify if:

• Metastases at diagnosis.
• Previous treatment with imatinib

Sponsors & Collaborators

• Italian Sarcoma Group: lead

Study Sites (13)

Azienda Ospedaliero-Universitaria Di Bologna

Bologna, BO, 40139, Italy

Location

Nuovo Ospedale di Prato

Prato, Firenze, 59100, Italy

Location

Istituto Europeo di Oncologia

Milan, MI, 20141, Italy

Location

Istituto Clinico Humanitas

Rozzano, MI, 20089, Italy

Location

Azienda Ospedaliera Universitaria Paolo Giaccone

Palermo, PA, 90127, Italy

Location

Centro di Riferimento Oncologico - Unit of Medical Oncology

Aviano, Pordenone, 33081, Italy

Location

Policlinico Universitario Campus Biomedico

Roma, RM, 00128, Italy

Location

Fondazione del Piemonte per l'Oncologia IRCC Candiolo

Candiolo, Torino, 10060, Italy

Location

Ospedale San Giovanni Bosco

Torino, TO, Italy

Location

Policlinico S.Orsola Malpighi - Unit of Medical Oncology

Bologna, 40138, Italy

Location

Azienda Ospedaliera Universitaria Careggi

Florence, 50100, Italy

Location

Fondazione IRCCS INT Milano

Milan, 20133, Italy

Location

Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I

Roma, 00144, Italy

Location

Related Publications (6)

• Joensuu H, Hohenberger P, Corless CL. Gastrointestinal stromal tumour. Lancet. 2013 Sep 14;382(9896):973-83. doi: 10.1016/S0140-6736(13)60106-3. Epub 2013 Apr 24.

  PMID: 23623056 BACKGROUND

• Gold JS, Gonen M, Gutierrez A, Broto JM, Garcia-del-Muro X, Smyrk TC, Maki RG, Singer S, Brennan MF, Antonescu CR, Donohue JH, DeMatteo RP. Development and validation of a prognostic nomogram for recurrence-free survival after complete surgical resection of localised primary gastrointestinal stromal tumour: a retrospective analysis. Lancet Oncol. 2009 Nov;10(11):1045-52. doi: 10.1016/S1470-2045(09)70242-6. Epub 2009 Sep 28.

  PMID: 19793678 BACKGROUND

• D'Ambrosio L, Palesandro E, Boccone P, Tolomeo F, Miano S, Galizia D, Manca A, Chiara G, Bertotto I, Russo F, Campanella D, Venesio T, Sangiolo D, Pignochino Y, Siatis D, De Simone M, Ferrero A, Pisacane A, Dei Tos AP, Aliberti S, Aglietta M, Grignani G. Impact of a risk-based follow-up in patients affected by gastrointestinal stromal tumour. Eur J Cancer. 2017 Jun;78:122-132. doi: 10.1016/j.ejca.2017.03.025. Epub 2017 Apr 24.

  PMID: 28448856 BACKGROUND

• Joensuu H, Reichardt P, Eriksson M, Sundby Hall K, Vehtari A. Gastrointestinal stromal tumor: a method for optimizing the timing of CT scans in the follow-up of cancer patients. Radiology. 2014 Apr;271(1):96-103. doi: 10.1148/radiol.13131040. Epub 2013 Nov 18.

  PMID: 24475826 BACKGROUND

• Rossi S, Miceli R, Messerini L, Bearzi I, Mazzoleni G, Capella C, Arrigoni G, Sonzogni A, Sidoni A, Toffolatti L, Laurino L, Mariani L, Vinaccia V, Gnocchi C, Gronchi A, Casali PG, Dei Tos AP. Natural history of imatinib-naive GISTs: a retrospective analysis of 929 cases with long-term follow-up and development of a survival nomogram based on mitotic index and size as continuous variables. Am J Surg Pathol. 2011 Nov;35(11):1646-56. doi: 10.1097/PAS.0b013e31822d63a7.

  PMID: 21997685 BACKGROUND

• Casali PG, Abecassis N, Aro HT, Bauer S, Biagini R, Bielack S, Bonvalot S, Boukovinas I, Bovee JVMG, Brodowicz T, Broto JM, Buonadonna A, De Alava E, Dei Tos AP, Del Muro XG, Dileo P, Eriksson M, Fedenko A, Ferraresi V, Ferrari A, Ferrari S, Frezza AM, Gasperoni S, Gelderblom H, Gil T, Grignani G, Gronchi A, Haas RL, Hassan B, Hohenberger P, Issels R, Joensuu H, Jones RL, Judson I, Jutte P, Kaal S, Kasper B, Kopeckova K, Krakorova DA, Le Cesne A, Lugowska I, Merimsky O, Montemurro M, Pantaleo MA, Piana R, Picci P, Piperno-Neumann S, Pousa AL, Reichardt P, Robinson MH, Rutkowski P, Safwat AA, Schoffski P, Sleijfer S, Stacchiotti S, Sundby Hall K, Unk M, Van Coevorden F, van der Graaf WTA, Whelan J, Wardelmann E, Zaikova O, Blay JY; ESMO Guidelines Committee and EURACAN. Gastrointestinal stromal tumours: ESMO-EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2018 Oct 1;29(Suppl 4):iv267. doi: 10.1093/annonc/mdy320. No abstract available.

  PMID: 30188977 BACKGROUND

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

• Giovanni Grignani

  giovanni.grignani@ircc.it

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 23, 2020
• Study Start: November 25, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 20, 2023
• Last Updated: February 1, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (13)