Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-25 @ 8:26 PM
Study NCT ID:
NCT02306967
Status:
COMPLETED
Last Update Posted:
2018-05-02
First Post:
2014-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluorescent Visualization in Early Oral Cancer
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': 'D009062', 'term': 'Mouth Neoplasms'}], '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': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-01', 'studyFirstSubmitDate': '2014-12-01', 'studyFirstSubmitQcDate': '2014-12-01', 'lastUpdatePostDateStruct': {'date': '2018-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease specific survival', 'timeFrame': '5 years', 'description': 'disease specific 5 year survival'}]}, 'conditionsModule': {'keywords': ['oral cancer', 'oral dysplasia'], 'conditions': ['Oral Squamous Cell Carcinoma or Severe Dysplasia']}, 'descriptionModule': {'briefSummary': 'Studies from Vancouver show that fluorescent visualization (FV) is a useful method of controlling surgical margins. This early finding will now be confirmed in a national randomized controlled trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* biopsy proven invasive oral cancer or severe dysplasia / Cis\n* invasive cancer must be T1 or T2\n* no prior history of oral cancer / treatment of oral cancer\n\nExclusion Criteria:\n\n* prior history of oral cancer\n* unable to provide informed consent\n* lesion not able to be completely visualized by FV'}, 'identificationModule': {'nctId': 'NCT02306967', 'briefTitle': 'Fluorescent Visualization in Early Oral Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'orgStudyIdInfo': {'id': 'UCENT004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Resection', 'description': 'Oral resection will be guided by usual practice. This involves identifying the tumour with white light and then marking surgical margins and resection the primary cancer.', 'interventionNames': ['Procedure: resection of oral cancer']}, {'type': 'EXPERIMENTAL', 'label': 'FV Guided Resection', 'description': 'The oral resection will be guided by fluorescent visualization (FV).', 'interventionNames': ['Procedure: resection of oral cancer']}], 'interventions': [{'name': 'resection of oral cancer', 'type': 'PROCEDURE', 'description': 'Oral cancer will be resected.', 'armGroupLabels': ['FV Guided Resection', 'Standard Resection']}, {'name': 'resection of oral cancer', 'type': 'PROCEDURE', 'description': 'Oral cancer will be resected', 'armGroupLabels': ['FV Guided Resection', 'Standard Resection']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4N1', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Foothills Hospital', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'collaborators': [{'name': 'Terry Fox Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Joseph C. Dort', 'investigatorAffiliation': 'University of Calgary'}}}}