Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2026-01-09 @ 4:30 AM
Study NCT ID:
NCT05935995
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-28
First Post:
2023-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative Assessment of Surgical Margins Using Confocal Microscopy in Comparison With Reference Extemporaneous Examination
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D002280', 'term': 'Carcinoma, Basal Cell'}, {'id': 'D000072662', 'term': 'Margins of Excision'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D018295', 'term': 'Neoplasms, Basal Cell'}, {'id': 'D065308', 'term': 'Morphological and Microscopic Findings'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D018613', 'term': 'Microscopy, Confocal'}], 'ancestors': [{'id': 'D008853', 'term': 'Microscopy'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2023-06-27', 'studyFirstSubmitQcDate': '2023-07-06', 'lastUpdatePostDateStruct': {'date': '2025-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and Specificity of Confocal Microscopy Diagnosis Compared to Gold Standard', 'timeFrame': '1 day', 'description': 'The concordance of intraoperative diagnosis between the two methods will be assessed by the condition of the margins of surgical specimens. Diagnostic accuracy will be measured by the sensitivity and specificity of confocal microscopy, using conventional histology reports from extemporaneous examination as the gold standard.\n\n* negative margins (absence of tumour cells) ;\n* positive margins (presence of tumour cells).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['margin surgical', 'confocal microscopy', 'conventional histopathology (H&E)'], 'conditions': ['Squamous Cell Carcinoma of Head and Neck', 'Basal Cell Carcinoma of Skin']}, 'descriptionModule': {'briefSummary': 'Study to evaluate the use of confocal microscopy for detecting resection margins in patients undergoing surgery for basal cell carcinoma of skin and squamous Cell Carcinoma of Head and Neck'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient ≥18 years old\n* Squamous cell or basal cell tumor (1 to 4 cm) of mucous or cutaneous origin.\n* Patient whose surgical indication has been validated in a consultation meeting\n* Patients with scheduled surgery\n* WHO\\< or =2\n* ASA \\< 3\n* Patient affiliated to the social security system\n* Patient has understood, signed and dated the consent form.\n\nExclusion Criteria:\n\n* History of irradiation in the surgical area\n* Women who are pregnant or who are breast-feeding.\n* Persons deprived of their liberty or under guardianship (including curators)'}, 'identificationModule': {'nctId': 'NCT05935995', 'acronym': 'HISTOBLOC', 'briefTitle': 'Intraoperative Assessment of Surgical Margins Using Confocal Microscopy in Comparison With Reference Extemporaneous Examination', 'organization': {'class': 'OTHER', 'fullName': 'Institut de Cancérologie de Lorraine'}, 'officialTitle': 'Intraoperative Assessment of Surgical Margins Using Confocal Microscopy in Comparison With Reference Extemporaneous Examination (Pilot Study)', 'orgStudyIdInfo': {'id': '2023-A00818-37'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Microscopy confocal', 'interventionNames': ['Other: microscopy confocal (Histolog Scanner)']}], 'interventions': [{'name': 'microscopy confocal (Histolog Scanner)', 'type': 'OTHER', 'description': 'Surgical margins of tumor samples will be examined by conventional histopathology (H\\&E) and confocal microscopy (Histolog® scanner, SamanTree Medical, Switzerland).\n\nDepending on the histopathological result obtained between the two methods, the patient may benefit directly from early surgery if the experimental result confirms the presence of positive margins (excluding the learning curve).\n\nA learning curve will be established over the first fifteen surgeries, enabling surgical teams to gain experience and systematize specimen flattening. This learning curve will also enable reference images to be produced. The procedure will be carried out by the surgeon and the pathologist in the operating room during this phase.', 'armGroupLabels': ['Microscopy confocal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54500', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Institut de Cancerologie de Lorraine', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}], 'overallOfficials': [{'name': 'GILLES DOLIVET, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut de Cancérologie de Lorraine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut de Cancérologie de Lorraine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}