protocolSection identificationModule nctId: NCT06324032, orgStudyIdInfo id: 021-FPO20, briefTitle: SUNNYDAY: SUbepithelialgastroiNtestiNal Tumors Detection,accuracYDiAgnosis,ElastographY and Contrast-enhanced EUS, acronym: SunnyDay021, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-12-17, primaryCompletionDateStruct date: 2025-06-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-21, lastUpdatePostDateStruct date: 2024-03-21, sponsorCollaboratorsModule leadSponsor name: Fondazione del Piemonte per l'Oncologia, class: OTHER, descriptionModule briefSummary: This will be a longitudinal, prospective, observational multicenter study where the role of EUS-E will be examined in differentiating subepithelial gastrointestinal tumors in 138 patients, conditionsModule conditions: Subepithelial Gastrointestinal Tumors, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 138, type: ESTIMATED, armsInterventionsModule interventions name: EUS Elastography (EUS-E), outcomesModule primaryOutcomes measure: Evaluation of EUS-E accuracy qualitative, primaryOutcomes measure: Evaluation of EUS-E accuracy quantitative, secondaryOutcomes measure: Evaluation of diagnostic accuracy of EUS-biopsy with fine needle biopsy (FNB), secondaryOutcomes measure: Evaluation of gene mutations in EUS-guided specimen, secondaryOutcomes measure: Correlation of elastographic and contrastographic characteristics of SETs with the pathological risk stratification., secondaryOutcomes measure: Complication rate (perforations, bleeding) of the procedure, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ospedale Santa Maria della Scaletta, status: RECRUITING, city: Imola, state: Bologna, country: Italy, contacts name: Pietro Fusaroli, MD, role: CONTACT, geoPoint lat: 44.35916, lon: 11.7132, locations facility: Istituto Clinico Humanitas, status: RECRUITING, city: Rozzano, state: Milano, country: Italy, contacts name: Silvia Carrara, MD, role: CONTACT, geoPoint lat: 45.38193, lon: 9.1559, locations facility: Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo, status: RECRUITING, city: Candiolo, state: Turin,, zip: 10060, country: Italy, contacts name: Teresa Staiano, MD, role: CONTACT, phone: +390119933413, email: teresa.staiano@ircc.it, geoPoint lat: 44.95858, lon: 7.59812, locations facility: Ospedale Humanitas Mater Domini, status: RECRUITING, city: Castellanza, state: Varese, country: Italy, contacts name: Benedetto Mangiavillano, MD, role: CONTACT, geoPoint lat: 45.61079, lon: 8.89616, locations facility: AOU Maggiore della Carità, status: RECRUITING, city: Novara, zip: 28100, country: Italy, contacts name: Pietro Occhipinti, MD, role: CONTACT, geoPoint lat: 45.44694, lon: 8.62118, locations facility: Istituto Oncologico Veneto, status: RECRUITING, city: Padova, country: Italy, contacts name: Alberto Fantin, MD, role: CONTACT, geoPoint lat: 45.40797, lon: 11.88586, locations facility: AOU Città della Salute e della Scienza di Torino, Ospedale Molinette, status: RECRUITING, city: Turin, zip: 10126, country: Italy, contacts name: Claudio G. De Angelis, MD, role: CONTACT, geoPoint lat: 45.07049, lon: 7.68682, hasResults: False