Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-03-02 @ 4:55 PM
Study NCT ID:
NCT02533518
Status:
COMPLETED
Last Update Posted:
2015-08-26
First Post:
2015-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultra-Violet Fluorescence Bronchial Cancer Location
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-24', 'studyFirstSubmitDate': '2015-08-17', 'studyFirstSubmitQcDate': '2015-08-24', 'lastUpdatePostDateStruct': {'date': '2015-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ultraviolet fluorescence ratio Iodine360 / Iodine450', 'timeFrame': 'Day 0', 'description': 'Detection of cancerous tissues and healthy or inflammatory tissues is used to calculate the sensitivity and specificity of the rigid bronchoscopy with UV transmission compared to biopsy (gold standard).'}, {'measure': 'Histology of tissue', 'timeFrame': 'Day 0', 'description': 'The histology give the final diagnosis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Diagnose lung cancer at an early stage is crucial for effective treatment. At these early stages, cancer is usually invisible in ambient white light when the endoscopic analysis of the bronchial mucosa. This lining is self-fluorescent at its illumination by blue light. These widely distributed autofluorescence methods detect early mucosal abnormalities. They are very sensitive but not specific to recognize the lung cancer. Thanks to European funding (EURIMUS), a new tool with fluorescent UV light has been developed.\n\nThe purpose of this preliminary study is to verify the suitability for specific detection of cancerous tissue in Pneumology of this fluorescence method versus histological analysis of the tissue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient affiliated or entitled to a social security scheme\n* Major Patient\n* Patient who signed the informed consent document\n* Patient with a known primary cancer in bronchial level\n\nExclusion Criteria:\n\n* Pregnant woman\n* Patient with a benign tumor histology\n* Patient with an unknown tumor histology.'}, 'identificationModule': {'nctId': 'NCT02533518', 'acronym': 'UVFBCL', 'briefTitle': 'Ultra-Violet Fluorescence Bronchial Cancer Location', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Ultra-Violet Fluorescence Bronchial Cancer Location', 'orgStudyIdInfo': {'id': '1008041'}, 'secondaryIdInfos': [{'id': '2010-A00343-36', 'type': 'OTHER', 'domain': 'AFSSAPS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients with lung cancer', 'interventionNames': ['Procedure: Rigid bronchoscopy with ultraviolet transmission', 'Other: Biopsy']}], 'interventions': [{'name': 'Rigid bronchoscopy with ultraviolet transmission', 'type': 'PROCEDURE', 'armGroupLabels': ['patients with lung cancer']}, {'name': 'Biopsy', 'type': 'OTHER', 'armGroupLabels': ['patients with lung cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'Pneumology departement CHU Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}