Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-30 @ 3:22 PM
Study NCT ID:
NCT06324032
Status:
RECRUITING
Last Update Posted:
2024-03-21
First Post:
2024-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SUNNYDAY: SUbepithelialgastroiNtestiNal Tumors Detection,accuracYDiAgnosis,ElastographY and Contrast-enhanced EUS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D061765', 'term': 'Endoscopic Ultrasound-Guided Fine Needle Aspiration'}], 'ancestors': [{'id': 'D044963', 'term': 'Biopsy, Fine-Needle'}, {'id': 'D001707', 'term': 'Biopsy, Needle'}, {'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D061705', 'term': 'Image-Guided Biopsy'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D018084', 'term': 'Ultrasonography, Interventional'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Biopsy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 138}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-15', 'studyFirstSubmitDate': '2024-02-15', 'studyFirstSubmitQcDate': '2024-03-15', 'lastUpdatePostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of EUS-E accuracy qualitative', 'timeFrame': '4 weeks', 'description': 'Evaluation of Endoscopic Ultrasound -Elastography (EUS-E)) accuracy (qualitative elastography) and contrast enhanced endoscopic ultrasound (CE-EUS) in the diagnosis of SETs compared to the histological data provided by the ultrasound-guided biopsy.\n\nthe elastographic qualitative pattern will be assessed and described using an elastographic score.\n\nELASTOGRAPHIC SCORE: three elastographic patterns will be used to define the stiffness of the SETs:\n\n* homogeneously green-pattern (soft)\n* mixed-type pattern (mild stiffness)\n* blue-predominant elastographic pattern (hard) Strain Ratio (SR) will be calculated by dividing the ROI placed on the normal GI wall at the periphery of the mass (ROI B) by the ROI placed on the lesion itself (ROI A). ROI A will be manually adjusted to cover the tumoral area as much as possible.'}, {'measure': 'Evaluation of EUS-E accuracy quantitative', 'timeFrame': '4 weeks', 'description': 'Evaluation of Endoscopic Ultrasound -Elastography (EUS-E) accuracy (quantitative elastography) and contrast enhanced endoscopic ultrasound (CE-EUS) in the diagnosis of SETs compared to the histological data provided by the ultrasound-guided biopsy.\n\nEUS-E compares the strain between the target area and other reference areas, to provide a semi-quantitative analysis of tissue stiffness.\n\nThe SR (B/A quotients) will be calculated by the diagnostic US imaging system. The SRs will be measured and recorded 3 times in each procedure; the mean value will be considered as the final result for data analysis(to establish an SR cut-off to differentiate GIST from other SETs). Videos of 5 seconds will be recorded per each measurement.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of diagnostic accuracy of EUS-biopsy with fine needle biopsy (FNB)', 'timeFrame': '4 weeks', 'description': 'Evaluation of diagnostic accuracy of Endoscopic Ultrasound biopsy (EUS-biopsy) with fine needle biopsy (FNB).\n\nIs obtained by evaluating the Strain Ratio (SR). Strain Ratio (SR) is a value resulting from the ratio between the stiffness of two user-defined areas within an elastogram ,which provides an objective evaluation of the hardness of lesion. Therefore, EUS-E has been applied to diseases of the pancreas, liver, prostate, lymphnodes, and other SETs'}, {'measure': 'Evaluation of gene mutations in EUS-guided specimen', 'timeFrame': '24 weeks', 'description': 'Evaluation of genetic mutations in ultrasound-guided endoscopic specimens by analyzing the tissue.\n\nAll specimens will undergo histopathological examination, immunohistochemical evaluation, and molecular analysis'}, {'measure': 'Correlation of elastographic and contrastographic characteristics of SETs with the pathological risk stratification.', 'timeFrame': '24 weeks', 'description': 'Correlation of elastographic and contrastographic characteristics of SubEpithelial Tumors (SETs) with the pathological risk stratification.\n\nThe elasticity of the tissues will be evaluated, which presents itself as a chromatic spectrum of shades and expressed graphically in an elastogram. The green color represents medium stiffness, blue reflects the hardest tissue and red the softest tissue.'}, {'measure': 'Complication rate (perforations, bleeding) of the procedure', 'timeFrame': '48 hours', 'description': 'Complication rate (perforations, bleeding) of the procedure will be obtained by evaluating the number of complications'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['subepithelial gastrointestinal tumors', 'Endoscopic Ultrasound', 'EUS', 'SETs', 'EUS Elastography', 'surgical resection', 'histopatological specimens'], 'conditions': ['Subepithelial Gastrointestinal Tumors']}, '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', 'detailedDescription': 'This will be a longitudinal, prospective, observational multicenter study that will enroll consecutive patients, with gastrointestinal SETs diagnosed by experienced endoscopists at Italian hospitals. This study will be conducted following the Helsinki Declaration after the approval by the ethics review board of all centers and will be recorded on Clinical-Trials.gov. All patients will provide their written informed consent for participating in the study. The EUS-E and CEUS analysis with SonoVue® will be performed during the same procedures. A subsequent diagnostic hypothesis on the nature of SETs will be formulated based on the B-mode, EUS-E, and CE-EUS characteristics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'for patients with all types of Gastro Intestinal SETs.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Patients with GI SETs scheduled for EUS-FNB 2 Patients with age \\> 18 but \\<85\n\nExclusion Criteria:\n\n1. Patients with GI SETs \\<15mm\n2. severe coagulopathy defined as abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma\n3. severe cardiopulmonary diseases and severe chronic kidney disease defined as\n4. known allergic disposition to SonoVue®\n5. pregnancy'}, 'identificationModule': {'nctId': 'NCT06324032', 'acronym': 'SunnyDay021', 'briefTitle': 'SUNNYDAY: SUbepithelialgastroiNtestiNal Tumors Detection,accuracYDiAgnosis,ElastographY and Contrast-enhanced EUS', 'organization': {'class': 'OTHER', 'fullName': "Fondazione del Piemonte per l'Oncologia"}, 'officialTitle': 'EUS-Elastography and Contrast-Enhanced EUS Diagnostic Accuracy in the Differential Diagnosis of Subepithelial Gastrointestinal Tumors: a Multicenter Prospective Observational Study', 'orgStudyIdInfo': {'id': '021-FPO20'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with subepithelial gastrointestinal tumors', 'description': 'Patients with subepithelial gastrointestinal tumors', 'interventionNames': ['Procedure: EUS Elastography (EUS-E)']}], 'interventions': [{'name': 'EUS Elastography (EUS-E)', 'type': 'PROCEDURE', 'otherNames': ['Endoscopic Ultrasound (EUS)', 'Contrast Enhanced-EUS (CE-EUS)'], 'description': 'All procedures will be performed with Olympus echoendoscopes (Olympus Europa SE \\& CO. KG, Hamburg, Germany) or Pentax echoendoscopes in combination with dedicated elastography software', 'armGroupLabels': ['Patients with subepithelial gastrointestinal tumors']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Imola', 'state': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pietro Fusaroli, MD', 'role': 'CONTACT'}], 'facility': 'Ospedale Santa Maria della Scaletta', 'geoPoint': {'lat': 44.35916, 'lon': 11.7132}}, {'city': 'Rozzano', 'state': 'Milano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Silvia Carrara, MD', 'role': 'CONTACT'}], 'facility': 'Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}, {'zip': '10060', 'city': 'Candiolo', 'state': 'Turin,', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Teresa Staiano, MD', 'role': 'CONTACT', 'email': 'teresa.staiano@ircc.it', 'phone': '+390119933413'}], 'facility': "Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo", 'geoPoint': {'lat': 44.95858, 'lon': 7.59812}}, {'city': 'Castellanza', 'state': 'Varese', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Benedetto Mangiavillano, MD', 'role': 'CONTACT'}], 'facility': 'Ospedale Humanitas Mater Domini', 'geoPoint': {'lat': 45.61079, 'lon': 8.89616}}, {'zip': '28100', 'city': 'Novara', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pietro Occhipinti, MD', 'role': 'CONTACT'}], 'facility': 'AOU Maggiore della Carità', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'city': 'Padua', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alberto Fantin, MD', 'role': 'CONTACT'}], 'facility': 'Istituto Oncologico Veneto', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}, {'zip': '10126', 'city': 'Turin', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Claudio G. De Angelis, MD', 'role': 'CONTACT'}], 'facility': 'AOU Città della Salute e della Scienza di Torino, Ospedale Molinette', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}], 'centralContacts': [{'name': 'Cristiana Laudi, MD', 'role': 'CONTACT', 'email': 'Cristiana.laudi@ircc.it', 'phone': '+390119933413'}, {'name': 'Marco Asioli, Dr', 'role': 'CONTACT', 'email': 'marco.asioli@ircc.it', 'phone': '+390119933463'}], 'overallOfficials': [{'name': 'Teresa Staiano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'FPO-IRCCS di Candiolo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'contact the principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fondazione del Piemonte per l'Oncologia", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}