Ignite Creation Date:
2025-12-24 @ 10:06 PM
Ignite Modification Date:
2026-01-01 @ 12:08 PM
Study NCT ID:
NCT02035735
Status:
COMPLETED
Last Update Posted:
2018-12-11
First Post:
2014-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of Narrow Band Imaging in Detection of Upper Aerodigestive Cancers
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': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D000072662', 'term': 'Margins of Excision'}], 'ancestors': [{'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': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D065308', 'term': 'Morphological and Microscopic Findings'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062048', 'term': 'Narrow Band Imaging'}], 'ancestors': [{'id': 'D061848', 'term': 'Optical Imaging'}, {'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': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-09', 'studyFirstSubmitDate': '2014-01-10', 'studyFirstSubmitQcDate': '2014-01-10', 'lastUpdatePostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients for whom superficial extension of the tumors has been increased by NBI.', 'timeFrame': '4 minutes'}], 'secondaryOutcomes': [{'measure': 'Number of tumors upstaged.', 'timeFrame': '4 minutes'}, {'measure': 'Contribution of the NBI in the diagnosis of other synchronous locations.', 'timeFrame': '4 minutes'}, {'measure': 'Contribution of the NBI in the diagnosis of pre-neoplastic lesions.', 'timeFrame': '4 minutes'}, {'measure': 'Contribution of the NBI in the evaluation of surgical margins.', 'timeFrame': '4 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NBI,', 'squamous cell carcinoma,', 'pharynx, larynx, surgical margins.'], 'conditions': ['Squamous Cell Carcinoma of Oropharynx', 'Squamous Cell Carcinoma of Hypopharynx', 'Squamous Cell Carcinoma of Larynx']}, 'referencesModule': {'references': [{'pmid': '33398548', 'type': 'DERIVED', 'citation': 'Chabrillac E, Espinasse G, Lepage B, Uro-Coste E, Dupret-Bories A, De Bonnecaze G, Vergez S. Contribution of narrow band imaging in delineation of laryngopharyngeal superficial cancer spread: a prospective study. Eur Arch Otorhinolaryngol. 2021 May;278(5):1491-1497. doi: 10.1007/s00405-020-06499-2. Epub 2021 Jan 5.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to prospectively determine if the use of NBI endoscopy modifies the superficial extension of these tumors.', 'detailedDescription': 'Several studies have already showed the interest of the use of NBI for the early diagnosis of malignancies of the upper aerodigestive tract. For all tumors, the most accurate evaluation of its limits is very important to perform the best strategy of treatment. If surgery seems to be the best option, surgical margins must be widely healthy. Despite the systematic transnasal flexible endoscopy with white lamp followed by laryngoscopy under general anesthesia (LGA) and tomodensitometric evaluation, surgical margins can be unhealthy (in situ carcinoma or dysplasia). We propose to evaluate if the use of the NBI could be useful to determine the superficial spread of squamous cell carcinomas in these locations.\n\nTo April 2013 to Mars 2015, all patients with a suspicion of squamous cell carcinoma of the oropharynx, hypopharynx or larynx and whom a LGA are expected, are included. The day before the LGA, two endoscopies by two different physicians were performed for each patients and recorded: the first one with white light and the second one with NBI. All results are noted on a schema. Superficial extension or synchronous lesions showed by NBI are analysed and compared with with lamp technic.\n\nAfter surgery, surgical margins were evaluated and healthy margins were measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients who can benefit a laryngoscopic exam under general anesthesia\n\nExclusion Criteria:\n\n* General anesthesia contra-indications\n* Local anesthesia allergy\n* Breast-feeding period or pregnancy'}, 'identificationModule': {'nctId': 'NCT02035735', 'briefTitle': 'Interest of Narrow Band Imaging in Detection of Upper Aerodigestive Cancers', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Usefulness of Narrow-band Imaging to Estimate the Superficial Spread of Squamous Cell Carcinomas in Oropharynx, Hypopharynx and Larynx', 'orgStudyIdInfo': {'id': '13 203 02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Videoendoscopy with WL and NBI', 'description': 'The day before the laryngoscopy under general anesthesia (LGA), two endoscopies by two different physicians were performed for each patients and recorded: the first one with white light (WL) and the second one with NBI (NBI).', 'interventionNames': ['Procedure: WL and NBI']}], 'interventions': [{'name': 'WL and NBI', 'type': 'PROCEDURE', 'description': 'For each patient with a suspicion of squamous cell carcinoma of the oropharynx, hypopharynx or larynx for whom a laryngoscopy under general anesthesia (LGA) is expected benefit the day before a transnasal endoscopy with white lamp (WL) and NBI by two different operators. Suspected mucosal abnormalities showed by one or the two technics are reported in a table wich describes the different areas of the pharynx and the larynx. During the LGA, several biopsies are performed and identified (WL and/or NBI).', 'armGroupLabels': ['Videoendoscopy with WL and NBI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'University of Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Sébastien VERGEZ, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}