GIST Clinical Trial
— RetroGISTOfficial title:
Follow-up in Low Risk Gastrointestinal Stromal Tumors (GISTs) - Retrospective Analysis of Clinical Features and Outcomes
Verified date | December 2023 |
Source | Italian Sarcoma Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
Status | Completed |
Enrollment | 700 |
Est. completion date | December 20, 2023 |
Est. primary completion date | December 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Centro di Riferimento Oncologico - Unit of Medical Oncology | Aviano | Pordenone |
Italy | Azienda Ospedaliero-Universitaria Di Bologna | Bologna | BO |
Italy | Policlinico S.Orsola Malpighi - Unit of Medical Oncology | Bologna | |
Italy | Fondazione del Piemonte per l'Oncologia IRCC Candiolo | Candiolo | Torino |
Italy | Azienda Ospedaliera Universitaria Careggi | Firenze | |
Italy | Fondazione IRCCS INT Milano | Milano | |
Italy | Istituto Europeo di Oncologia | Milano | MI |
Italy | Azienda Ospedaliera Universitaria Paolo Giaccone | Palermo | PA |
Italy | Nuovo Ospedale di Prato | Prato | Firenze |
Italy | Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I | Roma | |
Italy | Policlinico Universitario Campus Biomedico | Roma | RM |
Italy | Istituto Clinico Humanitas | Rozzano | MI |
Italy | Ospedale San Giovanni Bosco | Torino | TO |
Lead Sponsor | Collaborator |
---|---|
Italian Sarcoma Group |
Italy,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Disease-Specific survival (DSS) | Time elapsed for the diagnosis to the death of disease | at 5 years | |
Secondary | Overall survival (OS). | Time elapsed for the diagnosis to the death for any cause | at 5 years |
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