Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-03 @ 7:34 PM
Study NCT ID:
NCT03079232
Status:
COMPLETED
Last Update Posted:
2025-02-10
First Post:
2016-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
First Optical Coherence Microscopy in Dermato-oncology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012878', 'term': 'Skin Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'One group of patients One group of non skin cancer patients'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2016-03-16', 'studyFirstSubmitQcDate': '2017-03-08', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity', 'timeFrame': 'Day 1', 'description': 'Sensitivity measures the proportion of positive skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology)'}, {'measure': 'Specificity', 'timeFrame': 'Day 1', 'description': 'Specificity measures the proportion of negative skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology)'}], 'secondaryOutcomes': [{'measure': 'Measure of the thickness of the different skin layers (mm)', 'timeFrame': 'Day 1', 'description': 'Only for the non skin cancer group. Theses measures will identify the different skin layers (Epidermis, Dermis, Subcutaneous tissue, Cross-section)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Optical biopsy', 'Skin cancer', 'Diagnostic performance'], 'conditions': ['Skin Cancer']}, 'descriptionModule': {'briefSummary': 'OCTAV is a medical device class I, not CE marked, based on a new technique for high-resolution imager (cell) internal microstructures of all types of biological tissues in vivo or ex vivo, to a depth of penetration 800 .mu.m. It allows to explore the epidermis, the dermo-epidermal junction and middle dermis in a totally non-invasive (direct contact with the tissue without sampling).', 'detailedDescription': 'At the coming of the patient in Dermatology for resection / biopsy of the tumor (usual practice), for the study, an image of the tumor will be performed with the OCTAV device (about 5 minutes) for the study. Then, according to usual practice, resection / biopsy will be performed.\n\nThis study aims to validate the clinical relevance of this device to characterize the 3 main skin cancers and to obtain the necessary data for the implementation of future clinical trials.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'FOR PATIENT\n\nInclusion Criteria:\n\n* Patient with a cutaneous lesion suspicious for melanoma, basal cell carcinoma, squamous cell carcinoma, requiring a surgical excision\n* Consent form signed\n* Major patient\n\nExclusion Criteria:\n\n* Allergy or intolerance to immersion oil (used for microscopy)\n* If female, pregnant or breast-feeding\n* Patient unable to stand still for 60 seconds\n* Skin lesions located near patient eyes (\\<3 cm)\n\nFOR CONTROL GROUP\n\nInclusion Criteria:\n\n* Aged between 18 to 40 years\n* Consent form signed\n* Patient of the dermatology department with non-pathological forearm skin\n\nExclusion Criteria:\n\n* Allergy or intolerance to immersion oil (used for microscopy)\n* If female, pregnant or breast-feeding\n* Patient unable to stand still for 60 seconds'}, 'identificationModule': {'nctId': 'NCT03079232', 'acronym': 'GALAXY', 'briefTitle': 'First Optical Coherence Microscopy in Dermato-oncology', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'In Vivo Imaging Innovation : Optical Coherence Microscopy in Dermato-oncology', 'orgStudyIdInfo': {'id': '1608015'}, 'secondaryIdInfos': [{'id': '2016-A00319-42', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OCTAV Patient', 'description': 'The patients who will have a biopsy of skin suspected to be a melanoma, basal cell carcinoma or squamous cell carcinoma will have a skin imaging with a new Microscopy Optical Coherence (OCTAV)', 'interventionNames': ['Device: OCTAV Patient']}, {'type': 'EXPERIMENTAL', 'label': 'OCTAV Control group', 'description': 'Control group (patients without skin cancer) will have a skin imaging with a new Microscopy Optical Coherence (OCTAV)', 'interventionNames': ['Device: OCTAV Control group']}], 'interventions': [{'name': 'OCTAV Patient', 'type': 'DEVICE', 'otherNames': ['OCTAV, DAMAE Medical, Paris, France'], 'description': 'In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient.', 'armGroupLabels': ['OCTAV Patient']}, {'name': 'OCTAV Control group', 'type': 'DEVICE', 'otherNames': ['OCTAV, DAMAE Medical, Paris, France'], 'description': 'In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient.', 'armGroupLabels': ['OCTAV Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42000', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Chu de Saint Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Jean-Luc PERROT, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}, {'name': 'Cécile DUPONT, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Damae Medical'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'collaborators': [{'name': 'DAMAE Médical', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}