Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-25 @ 3:18 PM
Study NCT ID:
NCT03988959
Status:
COMPLETED
Last Update Posted:
2019-06-18
First Post:
2019-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surgical Management of Multiple Mucoepidermoid Carcinoma and Adenocarcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D018277', 'term': 'Carcinoma, Mucoepidermoid'}, {'id': 'D012468', 'term': 'Salivary Gland Neoplasms'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018297', 'term': 'Neoplasms, Cystic, Mucinous, and Serous'}, {'id': 'D009062', 'term': 'Mouth Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D012466', 'term': 'Salivary Gland Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'No masking was done since its a case series'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'a case series was performed on 7 patients having mucoepidermoid carcinoma'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-14', 'studyFirstSubmitDate': '2019-06-13', 'studyFirstSubmitQcDate': '2019-06-14', 'lastUpdatePostDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of life', 'timeFrame': '6 months', 'description': 'in grades the quality of life of patients is assessed by visual analogue scale in a scale from 1-10. higher values indicates better quality of life'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['salivary gland tumor'], 'conditions': ['Adenocarcinoma; Mucoepidermoid Carcinoma']}, 'descriptionModule': {'briefSummary': 'A case series of patient having mucoepidermoid carcinoma, had standard treatment protocol and surgeries and followup was performed and the patient postoperative quality of life and recurrent rate was recorded', 'detailedDescription': 'This case series presents mucoepidermoid carcinoma. Palatal mass was resected with safety margin then immediate opturator inserted; superficial parotidectomy was also done for parotid lesion sparing facial nerve. Post-operative radiotherapy was recommended by pathologist due to evident perineural spread. The patient is tumor free after one year follow-up.\n\nClinical reports about synchronous multiple salivary tumors are very rare, consequently there is little known about its management and clinical presentation. Presence of one or more risk factor should favor expectation of multiple tumors and mandate examination of all salivary tissues. Each tumor should be diagnosed and treated separately according to its nature and extension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients suffering from salivary gland tumor\n\nExclusion Criteria:\n\n* healthy patients with no tumors'}, 'identificationModule': {'nctId': 'NCT03988959', 'briefTitle': 'Surgical Management of Multiple Mucoepidermoid Carcinoma and Adenocarcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Surgical Management of Multiple Mucoepidermoid Carcinoma and Adenocarcinoma', 'orgStudyIdInfo': {'id': '110/2/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Control', 'description': 'Standard resection', 'interventionNames': ['Procedure: resection of mucoeidermoid carcinoma']}], 'interventions': [{'name': 'resection of mucoeidermoid carcinoma', 'type': 'PROCEDURE', 'otherNames': ['Conservative superficial partoidectomy'], 'description': 'Surgical resection parotid with preservation of facial nerve', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11757', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain shams university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mohamed Diaa, Prof Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dean of Faculty'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No plan to share those data currently with other researchers'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professour doctor and principle investigator in department of oral and maxillofacial surgery', 'investigatorFullName': 'Heba Sleem', 'investigatorAffiliation': 'Ain Shams University'}}}}