Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2025-12-29 @ 10:31 PM
Study NCT ID:
NCT06704256
Status:
RECRUITING
Last Update Posted:
2024-11-26
First Post:
2024-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SCM Muscle as a Marker for Frailty in Patients Undergoing ENT Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-10-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-22', 'studyFirstSubmitDate': '2024-11-22', 'studyFirstSubmitQcDate': '2024-11-22', 'lastUpdatePostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skeletal muscle size', 'timeFrame': 'End of study at 6 months', 'description': 'Skeletal muscle derived measures of size of neck skeletal musculature. No maximum or minimum.'}, {'measure': 'Skeletal muscle density', 'timeFrame': 'End of study at 6 months', 'description': 'Skeletal muscle derived measures of density of neck skeletal musculature. No maximum or minimum.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Frailty']}, 'descriptionModule': {'briefSummary': 'This study focuses on evaluating the relationship between physical frailty and measurements of the muscles of the neck in patients undergoing non-cancer Head and Neck surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Non-oncologic patients presenting for head and neck surgery with available neck CT scans', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Non-oncologic patients presenting for head and neck surgery with available neck CT scans.\n\nExclusion Criteria:\n\n* Patients undergoing cancer surgery\n* Patients under18 years of age\n* Patients without pre-surgical CT-scans of the head and neck'}, 'identificationModule': {'nctId': 'NCT06704256', 'briefTitle': 'SCM Muscle as a Marker for Frailty in Patients Undergoing ENT Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'SCM Muscle as a Marker for Frailty in Patients Undergoing ENT Surgery', 'orgStudyIdInfo': {'id': 'STUDY-24-00751'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients Undergoing Non-Oncologic and Neck surgery', 'description': 'Non-oncologic patients presenting for head and neck surgery with available neck CT scans.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10028', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Mingyang Gray, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Gabriela Hernandez, MD PhD', 'role': 'CONTACT', 'email': 'Gabriela.hernandezmeza@mountsinai.org', 'phone': '814-769-1104'}, {'name': 'Mingyang Gray, MD', 'role': 'CONTACT', 'email': 'Mgray@nyee.com'}], 'overallOfficials': [{'name': 'Gabriela Hernandez', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Immediately following publication. No end date.', 'ipdSharing': 'YES', 'description': 'All of the individual participant data collected during the trial, after deidentification.', 'accessCriteria': "Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.\n\nAny purpose. Data are available indefinitely at (Link to be included in the URL field below)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor Facial Plastic and Reconstructive Surgery Department of Otolaryngology - Head and Neck Surgery', 'investigatorFullName': 'Mingyang L Gray', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}