Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-27 @ 4:45 PM
Study NCT ID:
NCT04892966
Status:
COMPLETED
Last Update Posted:
2022-11-03
First Post:
2021-05-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TXI for the Recognition of Adenomas in Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 747}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-02', 'studyFirstSubmitDate': '2021-05-03', 'studyFirstSubmitQcDate': '2021-05-18', 'lastUpdatePostDateStruct': {'date': '2022-11-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adenoma Detection Rate (ADR)', 'timeFrame': '1 year', 'description': 'the proportion of participants with at least one adenoma (per-patient analysis)'}], 'secondaryOutcomes': [{'measure': 'Advanced ADR', 'timeFrame': '1 year', 'description': 'as the proportion of participants with at least one advanced adenoma at a per-patient analysis'}, {'measure': 'polyps, adenomas, advanced adenomas and Sessile Serrated Polyps (SSP) per subject', 'timeFrame': '1 year', 'description': 'the total number of detected lesions in each group divided by the total number of participants (per polyp analysis)'}, {'measure': 'proximal and flat adenomas detection rate', 'timeFrame': '1 year', 'description': 'the total number of detected lesions in each group divided by the total number of participants (per-polyp analysis)'}, {'measure': 'Withdrawal time', 'timeFrame': '1 year', 'description': 'Time from the start of the inspection at the cecum and the withdrawal of the colonoscope from the body of the patient.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Polyp']}, 'referencesModule': {'references': [{'pmid': '37451283', 'type': 'DERIVED', 'citation': 'Antonelli G, Bevivino G, Pecere S, Ebigbo A, Cereatti F, Akizue N, Di Fonzo M, Coppola M, Barbaro F, Walter BM, Sharma P, Caruso A, Okimoto K, Antenucci C, Matsumura T, Zerboni G, Grossi C, Meinikheim M, Papparella LG, Correale L, Costamagna G, Repici A, Spada C, Messmann H, Hassan C, Iacopini F. Texture and color enhancement imaging versus high definition white-light endoscopy for detection of colorectal neoplasia: a randomized trial. Endoscopy. 2023 Dec;55(12):1072-1080. doi: 10.1055/a-2129-7254. Epub 2023 Jul 14.'}]}, 'descriptionModule': {'briefSummary': 'This two parallel arms, randomized, multicenter trial is aimed at evaluating whether TXI is superior to WLI endoscopy in terms of adenoma detection. Secondary aims will be advanced adenoma detection rate, serrated polyp/adenoma detection rate, as well as procedure variables such as withdrawal time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n\\- All \\>40 years-old patients undergoing a colonoscopy for primary screening, Faecal Immunochemical Test (FIT) +, post-polypectomy surveillance\n\nExclusion criteria:\n\n* patients with personal history of colorectal cancer (CRC), or Inflammatory Bowel Disease (IBD).\n* Patients affected with Lynch syndrome or Familiar Adenomatous Polyposis.\n* patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale \\<2 in any colonic segment).\n* patients with previous colonic resection.\n* patients on antithrombotic therapy, precluding polyp resection.\n* patients who were not able or refused to give informed written consent.'}, 'identificationModule': {'nctId': 'NCT04892966', 'acronym': 'TRACK', 'briefTitle': 'TXI for the Recognition of Adenomas in Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Texture and Color Enhancement Imaging (TXI) Versus Standard White-light (WLI) Colonoscopy for Colorectal Adenoma Detection: a Multicenter, Randomized, Trial', 'orgStudyIdInfo': {'id': 'TRACK_GA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TXI (TXI group)', 'description': 'Arm undergoing normal colonoscopy with TXI light', 'interventionNames': ['Diagnostic Test: TXI Light Imaging']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'WLI (White Light Imaging Group)', 'description': 'Arm undergoing normal colonoscopy with standard white light', 'interventionNames': ['Diagnostic Test: WLI Imaging']}], 'interventions': [{'name': 'TXI Light Imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'Standard Colonoscopy using TXI imaging', 'armGroupLabels': ['TXI (TXI group)']}, {'name': 'WLI Imaging', 'type': 'DIAGNOSTIC_TEST', 'description': 'Standard Colonoscopy using White Light Imaging', 'armGroupLabels': ['WLI (White Light Imaging Group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00040', 'city': 'Ariccia', 'state': 'Rome', 'country': 'Italy', 'facility': 'Ospedale Dei Castelli', 'geoPoint': {'lat': 41.72063, 'lon': 12.6723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Consultant Gastroenterologist, PhD Student', 'investigatorFullName': 'Giulio Antonelli', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}