Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:18 AM
Study NCT ID:
NCT03385720
Status:
RECRUITING
Last Update Posted:
2023-03-30
First Post:
2017-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Submandibular Gland Preservation in Neck Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009062', 'term': 'Mouth Neoplasms'}], 'ancestors': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2030-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-28', 'studyFirstSubmitDate': '2017-12-06', 'studyFirstSubmitQcDate': '2017-12-20', 'lastUpdatePostDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '5-year survival rate', 'timeFrame': '5-year after operation', 'description': 'disease free survival rate'}, {'measure': '3-year survival rate', 'timeFrame': '3-year after operation', 'description': 'disease free survival rate'}, {'measure': '5-year regional recurrence rate', 'timeFrame': '5-year after operation', 'description': 'rate of participants with tumor recurrence in the neck'}, {'measure': '3-year regional recurrence rate', 'timeFrame': '3-year after operation', 'description': 'rate of participants with tumor recurrence in the neck'}, {'measure': '1-year regional recurrence rate', 'timeFrame': '1-year after operation', 'description': 'rate of participants with tumor recurrence in the neck'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neck Dislocation', 'Oral Cancer']}, 'descriptionModule': {'briefSummary': 'Trial design: a randomized controlled trial.\n\nEligibility criteria for participants: patients with primary early stage oral squamous cell carcinoma. Exclusion criteria: cancer of the floor of the mouth.\n\nInterventions: submandibular gland is preserved during neck dissection for patients of the experimental group; submandibular gland is removed during neck dissection for patients of the control group.\n\nPrimary Parameters: survival rate, mortality rate'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPrimary oral squamous cell carcinoma of early stage (T1N0 and T2N0).\n\nExclusion Criteria:\n\nCancer of the floor of the mouth.'}, 'identificationModule': {'nctId': 'NCT03385720', 'briefTitle': 'Submandibular Gland Preservation in Neck Dissection', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'Submandibular Gland Preservation During Neck Dissection for Oral Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': 'sujiazeng'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'interventionNames': ['Procedure: modified neck dissection']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'interventionNames': ['Procedure: traditional neck dissection']}], 'interventions': [{'name': 'modified neck dissection', 'type': 'PROCEDURE', 'description': 'Modified neck dissection with preservation of submandibular gland. The submandibular gland is preserved during neck dissection.', 'armGroupLabels': ['Experimental group']}, {'name': 'traditional neck dissection', 'type': 'PROCEDURE', 'description': 'traditional neck dissection without preservation of submandibular gland', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100081', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guang-Yan Yu, Professor', 'role': 'CONTACT', 'email': 'gyyu@263.net', 'phone': '86 10 13426227717'}], 'facility': 'Peking University School of Stomatology', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Jia-Zeng Su, Dr.', 'role': 'CONTACT', 'email': 'sujiazeng@163.com', 'phone': '86 10 82195992'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guang-Yan Yu', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Natural Science Foundation of China', 'class': 'OTHER_GOV'}, {'name': 'Peking University School of Stomatology', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'President of Chinese Stomatological Association', 'investigatorFullName': 'Guang-Yan Yu', 'investigatorAffiliation': 'Peking University'}}}}