protocolSection identificationModule nctId: NCT06271603, orgStudyIdInfo id: 23.02645.000357-MS01, secondaryIdInfos id: CPP Ile de France III, type: OTHER, domain: 23.02645.000357-MS01, briefTitle: Evaluation of the Efficiency and Economic Impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the Diagnosis and Management of Basal Cell Carcinomas, acronym: ECOBASO, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2026-02, completionDateStruct date: 2026-02, studyFirstPostDateStruct date: 2024-02-22, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: Damae Medical, class: INDUSTRY, descriptionModule briefSummary: This is a comparative, randomized, prospective, multicenter clinical investigation aimed at evaluating the efficiency and economic impact of LC-OCT (Line-field Confocal Optical Coherence Tomography) for the diagnosis and management of basal cell carcinomas., conditionsModule conditions: Basal Cell Carcinoma of the Skin, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 704, type: ESTIMATED, armsInterventionsModule interventions name: diagnosis based on deepLive™ LC-OCT device, interventions name: diagnosis based on skin biopsy, outcomesModule primaryOutcomes measure: The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management., primaryOutcomes measure: The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management., primaryOutcomes measure: The primary objective is to demonstrate, at 1 year, the clinical non-inferiority and organizational and economic superiority of the management of primary BCC through diagnosis with LC-OCT compared to traditional management., secondaryOutcomes measure: Compare, after the diagnosis announcement and at 1 year, the quality of life of patients in the LC-OCT arm versus the standard management arm., secondaryOutcomes measure: Compare, after the diagnosis announcement and at 1 year, the anxiety levels of patients in the LC-OCT arm versus the standard management arm., secondaryOutcomes measure: Compare patient satisfaction with their management at 1 year in the LC-OCT arm versus the standard management arm., secondaryOutcomes measure: Evaluate the performance of LC-OCT for the diagnosis and subtyping of BCC for all patients operated on or biopsied in the LC-OCT arm., secondaryOutcomes measure: Compare dermatologists' satisfaction with patient management in the LC-OCT arm versus the standard management arm, secondaryOutcomes measure: Estimate the actual cost of conducting the diagnosis with LC-OCT technology., secondaryOutcomes measure: Compare healthcare consumption between the two groups at 1 year., secondaryOutcomes measure: Conduct a cost-consequence analysis of patient management with LC-OCT technology versus standard management., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hôpital Ambroise Paré, city: Boulogne-Billancourt, zip: 92100, country: France, contacts name: Professeur Philippe SAIAG, role: CONTACT, phone: 800-555-5555, email: philippe.saiag@uvsq.fr, contacts name: Philippe SAIAG, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 48.83333, lon: 2.25, hasResults: False