Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-28 @ 4:18 PM
Study NCT ID:
NCT02851693
Status:
WITHDRAWN
Last Update Posted:
2019-04-04
First Post:
2016-07-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Imaging Characteristics OCT of Skin Lesions Requiring Biopsy / Resection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, 'conditionBrowseModule': {'meshes': [{'id': 'D018198', 'term': 'Mixed Tumor, Malignant'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D007642', 'term': 'Keratosis'}], 'ancestors': [{'id': 'D018193', 'term': 'Neoplasms, Complex and Mixed'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No open study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-02', 'studyFirstSubmitDate': '2016-07-28', 'studyFirstSubmitQcDate': '2016-07-28', 'lastUpdatePostDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'composite endpoint', 'timeFrame': 'at baseline', 'description': 'thickness of the epidermis (µm), thickness of the dermis (µm), limit of epidermis/dermis, homogeneity of the epidermis, homogeneity and structure of the papillary dermis, vascular network associated, homogeneity of the reticular dermis, wall of vacuoles and nodules (presence or absence)'}], 'secondaryOutcomes': [{'measure': 'implementation duration', 'timeFrame': 'at baseline', 'description': 'minutes'}, {'measure': 'acquisition practices duration', 'timeFrame': 'at baseline', 'description': 'minutes'}, {'measure': 'the duration of analysis image', 'timeFrame': 'at baseline', 'description': 'minutes'}, {'measure': 'utility of labeling with a dye for histology to locate the lesion', 'timeFrame': 'at baseline', 'description': 'yes or no'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mixed Tumor, Malignant', 'Biopsy', 'Resection', 'Carcinoma', 'Keratosis']}, 'descriptionModule': {'briefSummary': 'The diagnosis of cutaneous lesions often involves the use of surgical and invasive procedures such as biopsy or excision in order to analyze the structure and appearance of the fabric pathologists. With recent advances in optical and electronic fields, considerable efforts were produced to build high-performance optical instruments, able to transcribe the internal structure of the skin with varying degrees of depth and variable resolution.\n\nThe imagery is now an area of great interest for medical diagnosis: non-invasive, quick, and in real time. This area is booming and new optical instruments are created to eventually be able to offer a reliable alternative to invasive techniques.\n\nThe optical properties of different tissues have been studied for several years by different research groups: the coefficient of light absorption by the tissue both in vivo and in vitro, the coefficient of light scattering or the index refractive were characterized in various tissues that make up the skin.\n\nOther studies have focused on melanoma detection by multispectral optical techniques, or via the technique of optical coherence tomography (OCT) performed on lesions suspicious for cancer, but without linking criteria between these two techniques.\n\nHowever, no study to date and to our knowledge has been able to demonstrate the different optical parameters obtained with OCT and can be directly connected to known and histopathological parameters commonly used in the diagnosis of lesions skin. This study aims to verify if it is possible to determine the parameters measured in OCT that would discriminate between benign and malignant lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with suspicious skin lesions of malignant tumor (mostly non-melanoma: basal cell carcinoma, epidermoid carcinoma and actinic keratoses, or melanoma: melanoma, nevi) requiring biopsy / surgical excision;\n* consent signed\n\nExclusion Criteria:\n\n* Any dermatosis, hyperalgesic lesion, and / or infected and / or topography making it impossible measurements;\n* pregnant and nursing women\n* patients under tutorship or curatorship'}, 'identificationModule': {'nctId': 'NCT02851693', 'acronym': 'OCTSKIN', 'briefTitle': 'Study of Imaging Characteristics OCT of Skin Lesions Requiring Biopsy / Resection', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Study of Imaging Characteristics OCT of Skin Lesions Requiring Biopsy / Resection', 'orgStudyIdInfo': {'id': '1608069'}, 'secondaryIdInfos': [{'id': '2016-A00647-44', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Optical Coherence Tomography (OCT)', 'interventionNames': ['Device: Optical Coherence Tomography (OCT) with Vivosight', 'Device: Optical Coherence Tomography (OCT) with Skintell']}], 'interventions': [{'name': 'Optical Coherence Tomography (OCT) with Vivosight', 'type': 'DEVICE', 'otherNames': ['VIVOSIGHT (Michelson Diagnostics Ltd, Maidstone, Kent, UK)'], 'description': 'OCT used is Vivosight for diagnosis', 'armGroupLabels': ['Optical Coherence Tomography (OCT)']}, {'name': 'Optical Coherence Tomography (OCT) with Skintell', 'type': 'DEVICE', 'otherNames': ['SKINTELL (Agfa HealthCare, Heverlee, Belgium)'], 'description': 'OCT used is Skintell for diagnosis', 'armGroupLabels': ['Optical Coherence Tomography (OCT)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jean Luc PERROT, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Saint Etienne'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Research Agency, France', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}