Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-26 @ 4:16 PM
Study NCT ID:
NCT03727594
Status:
UNKNOWN
Last Update Posted:
2018-11-01
First Post:
2018-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radioguided Selective Neck Dissection for Staging and Treatment of Oral Cavity and Oropharyngeal Squamous Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-31', 'studyFirstSubmitDate': '2018-07-08', 'studyFirstSubmitQcDate': '2018-10-31', 'lastUpdatePostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with atypical lymphatic drainage of oral cavity and oropharyngeal squamous cell carcinoma identified through lymphoscintigraphy', 'timeFrame': '5 years'}, {'measure': 'Number of metastasis or micrometastasis in the "sentinel" lymphnodes identified through immunofluorescence analysis of pancytokeratins', 'timeFrame': '5 years'}, {'measure': 'Overall survival', 'timeFrame': '5 years', 'description': 'Prognosis of radioguided neck dissection surgery compared to the standardized neck dissection traditionally performed in consideration of the site and the characteristics of the tumor and the clinical status of lymphnodes.'}, {'measure': 'Disease-free survival', 'timeFrame': '5 years', 'description': 'Prognosis of radioguided neck dissection surgery compared to the standardized neck dissection traditionally performed in consideration of the site and the characteristics of the tumor and the clinical status of lymphnodes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oral Cavity Squamous Cell Carcinoma', 'Oropharyngeal Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the role of lymphoscintigraphy as a simple and widely accessible method with a favorable cost/benefit ratio in improving oral cavity and oropharyngeal squamous cell carcinoma staging and surgical appropriateness and implementing a tailored surgical approach to cervical lymph node dissection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '95 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients affected by oral cavity or oropharyngeal squamous cell carcinoma admitted to our clinic.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* accepted informed consent\n* preoperative histological diagnosis of oral cavity or oropharyngeal squamous cell carcinoma\n* patients fit to surgery of the primitive tumor and neck dissection (according to the general health condition and the clinical tumor stage)\n\nExclusion Criteria:\n\n* rejected informed consent\n* patients not fit to surgery (according to the general health condition and the clinical tumor stage)\n* pregnant women'}, 'identificationModule': {'nctId': 'NCT03727594', 'briefTitle': 'Radioguided Selective Neck Dissection for Staging and Treatment of Oral Cavity and Oropharyngeal Squamous Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital of Ferrara'}, 'officialTitle': 'Radioguided Selective Neck Dissection for Staging and Treatment of Oral Cavity and Oropharyngeal Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': '151099'}}, 'contactsLocationsModule': {'locations': [{'zip': '44124', 'city': 'Ferrara', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Nicola Malagutti, MD', 'role': 'CONTACT', 'email': 'nicolamalagutti@gmail.com', 'phone': '+393339011406'}], 'facility': 'University Hospital of Ferrara', 'geoPoint': {'lat': 44.83804, 'lon': 11.62057}}], 'centralContacts': [{'name': 'Nicola Malagutti, MD', 'role': 'CONTACT', 'email': 'nicolamalagutti@gmail.com', 'phone': '+393339011406'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital of Ferrara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nicola Malagutti', 'investigatorAffiliation': 'University Hospital of Ferrara'}}}}