Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-02-24 @ 10:52 AM
Study NCT ID:
NCT04599660
Status:
COMPLETED
Last Update Posted:
2024-02-01
First Post:
2020-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study in Low Risk Gastrointestinal Stromal Tumor (GISTs)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-31', 'studyFirstSubmitDate': '2020-10-15', 'studyFirstSubmitQcDate': '2020-10-17', 'lastUpdatePostDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To describe the most relevant features of follow-up in very-low and low risk GIST patients', 'timeFrame': 'Change from diagnosis (baseline)', 'description': 'Collection of retrospectively imaging characteristics'}, {'measure': 'To describe the most relevant features of follow-up in very-low and low risk GIST patients', 'timeFrame': 'At 1 year', 'description': 'Collection of retrospectively imaging characteristics.'}, {'measure': 'To describe the most relevant features of follow-up in very-low and low risk GIST patients', 'timeFrame': 'At 2 years', 'description': 'Collection of retrospectively imaging characteristics.'}, {'measure': 'To describe the most relevant features of follow-up in very-low and low risk GIST patients', 'timeFrame': 'At 3 years', 'description': 'Collection of retrospectively imaging characteristics.'}, {'measure': 'To describe the most relevant features of follow-up in very-low and low risk GIST patients', 'timeFrame': 'At 5 years', 'description': 'Collection of retrospectively imaging characteristics.'}, {'measure': 'To evaluate the onset of other neoplasms in very-low and low risk GIST patients', 'timeFrame': 'Chage from baseline (time of diagnosis) at 5 years', 'description': 'Onset of other neoplasm will be recoreded'}], 'secondaryOutcomes': [{'measure': 'To assess baseline clinical and disease-specific factors with possible impact on survival analyses.', 'timeFrame': 'Every 3 months (Month 3, Month 6, Month 9...) up to 5 years', 'description': 'Collection of clinical symptoms, pathological and molecular characteristics at disease presentation/diagnosis'}, {'measure': 'Recurrence-free survival (RFS)', 'timeFrame': 'Every 3 months (Month 3, Month 6, Month 9...) up to 5 years', 'description': 'Time elapsed form the treatment (any) start and the onset of recurrence'}, {'measure': 'Post-recurrence progression-free survival (PR-PFS)', 'timeFrame': 'Every 3 months (Month 3, Month 6, Month 9...) up to 5 years', 'description': 'Time elapsed form the onset of 1st progression to a further progression'}, {'measure': 'Disease-Specific survival (DSS)', 'timeFrame': 'at 5 years', 'description': 'Time elapsed for the diagnosis to the death of disease'}, {'measure': 'Overall survival (OS).', 'timeFrame': 'at 5 years', 'description': 'Time elapsed for the diagnosis to the death for any cause'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['GIST', 'Gastro Intestinal Stromal Tumor'], 'conditions': ['GIST']}, 'referencesModule': {'references': [{'pmid': '23623056', 'type': 'BACKGROUND', '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.'}, {'pmid': '19793678', 'type': 'BACKGROUND', '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.'}, {'pmid': '28448856', 'type': 'BACKGROUND', '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."}, {'pmid': '24475826', 'type': 'BACKGROUND', '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.'}, {'pmid': '21997685', 'type': 'BACKGROUND', '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.'}, {'pmid': '30188977', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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', 'detailedDescription': '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.\n\nAfter 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.\n\nOn 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.\n\nThe 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients affected by primary GIST at very-low and low risk of recurrence/progression, referred to participating Institutions between January 2000 and February 2020.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years at diagnosis\n* primary GIST removed by surgery or endoscopic procedures\n* availability of medical data needed for the study\n* very-low and low risk GIST defined as:\n\n * largest size of \\< 3 cm (for all sites of origin)\n * gastric GIST with ≤ 5/50 High Power Fields (HPF) mitoses and ≤ 10 cm in the largest size\n * gastric GIST with \\> 5/50 HPF mitoses and ≤ 5 cm in the largest size\n * intestinal GIST with ≤ 5/50 HPF mitoses and ≤ 5 cm in the largest size\n\nExclusion Criteria:\n\n* Metastases at diagnosis.\n* Previous treatment with imatinib'}, 'identificationModule': {'nctId': 'NCT04599660', 'acronym': 'RetroGIST', 'briefTitle': 'Study in Low Risk Gastrointestinal Stromal Tumor (GISTs)', 'organization': {'class': 'NETWORK', 'fullName': 'Italian Sarcoma Group'}, 'officialTitle': 'Follow-up in Low Risk Gastrointestinal Stromal Tumors (GISTs) - Retrospective Analysis of Clinical Features and Outcomes', 'orgStudyIdInfo': {'id': 'ISG-RetroGIST LR'}}, 'armsInterventionsModule': {'armGroups': [{'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.', 'interventionNames': ['Other: Treatment of Low Risk GISTs according clinical practice (includes drugs, surgery or any other received treatments)']}], 'interventions': [{'name': 'Treatment of Low Risk GISTs according clinical practice (includes drugs, surgery or any other received treatments)', 'type': 'OTHER', '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', 'armGroupLabels': ['Low Risk GISTs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40139', 'city': 'Bologna', 'state': 'BO', 'country': 'Italy', 'facility': 'Azienda Ospedaliero-Universitaria Di Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '59100', 'city': 'Prato', 'state': 'Firenze', 'country': 'Italy', 'facility': 'Nuovo Ospedale di Prato', 'geoPoint': {'lat': 43.8805, 'lon': 11.09699}}, {'zip': '20141', 'city': 'Milan', 'state': 'MI', 'country': 'Italy', 'facility': 'Istituto Europeo di Oncologia', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '20089', 'city': 'Rozzano', 'state': 'MI', 'country': 'Italy', 'facility': 'Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '90127', 'city': 'Palermo', 'state': 'PA', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Paolo Giaccone', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'zip': '33081', 'city': 'Aviano', 'state': 'Pordenone', 'country': 'Italy', 'facility': 'Centro di Riferimento Oncologico - Unit of Medical Oncology', 'geoPoint': {'lat': 46.07056, 'lon': 12.59472}}, {'zip': '00128', 'city': 'Roma', 'state': 'RM', 'country': 'Italy', 'facility': 'Policlinico Universitario Campus Biomedico', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '10060', 'city': 'Candiolo', 'state': 'Torino', 'country': 'Italy', 'facility': "Fondazione del Piemonte per l'Oncologia IRCC Candiolo", 'geoPoint': {'lat': 44.95858, 'lon': 7.59812}}, {'city': 'Torino', 'state': 'TO', 'country': 'Italy', 'facility': 'Ospedale San Giovanni Bosco', 'geoPoint': {'lat': 44.88856, 'lon': 11.99138}}, {'zip': '40138', 'city': 'Bologna', 'country': 'Italy', 'facility': 'Policlinico S.Orsola Malpighi - Unit of Medical Oncology', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'zip': '50100', 'city': 'Florence', 'country': 'Italy', 'facility': 'Azienda Ospedaliera Universitaria Careggi', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'zip': '20133', 'city': 'Milan', 'country': 'Italy', 'facility': 'Fondazione IRCCS INT Milano', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '00144', 'city': 'Roma', 'country': 'Italy', 'facility': 'Istituto Nazionale Tumori Regina Elena - Unit of Medical Oncology I', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'overallOfficials': [{'name': 'Giovanni Grignani', 'role': 'STUDY_CHAIR', 'affiliation': 'giovanni.grignani@ircc.it'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Italian Sarcoma Group', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}