Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2025-12-25 @ 3:07 PM
Study NCT ID:
NCT05446259
Status:
RECRUITING
Last Update Posted:
2025-10-27
First Post:
2022-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Degenerative Cervical Myelopathy Repository
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood specimens will be collected and banked for future IRB approved research studies.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 245}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2028-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-23', 'studyFirstSubmitDate': '2022-07-01', 'studyFirstSubmitQcDate': '2022-07-01', 'lastUpdatePostDateStruct': {'date': '2025-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Data comparison between DCM and control groups', 'timeFrame': '2 years', 'description': 'This study is to determine biomarkers associated with DCM and analyze objective clinical measures to determine more predictable and potentially effective treatments for patients diagnosed with cervical myelopathy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cervical Myelopathy']}, 'descriptionModule': {'briefSummary': 'To create a research repository of patients with known degenerative cervical myelopathy (DCM) and a control cohort of subjects who have non-myelopathic spinal disease. This repository will be used to assess functional and/or biological measures that may allow for improved prediction of symptomatic progression and response to treatment in patients with DCM. In addition, this repository will be used to develop a risk assessment scale to accurately predict functional outcomes following operative management of DCM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will be those diagnosed with degenerative cervical myelopathy, and those with cervical degenerative disease who do not experience myelopathic symptoms. Participating subjects will be required to sign the approved informed consent.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of degenerative cervical myelopathy\n* Diagnosis of cervical degenerative disease without myelopathy\n\nExclusion Criteria:\n\n* None outside or diagnostic requirements and age limits.'}, 'identificationModule': {'nctId': 'NCT05446259', 'acronym': 'DCM', 'briefTitle': 'Degenerative Cervical Myelopathy Repository', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Development of a Predictive Outcome Model for Patients With Degenerative Cervical Myelopathy Using Objective Functional and Biological Measures.', 'orgStudyIdInfo': {'id': '78340'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'DCM group', 'description': 'Subjects diagnosed with degenerative cervical myelopathy.', 'interventionNames': ['Other: Standard clinical care procedures and outcome measurements.']}, {'label': 'Control group', 'description': 'Subjects diagnosed with cervical spinal disease without myelopathic symptoms.', 'interventionNames': ['Other: Standard clinical care procedures and outcome measurements.']}], 'interventions': [{'name': 'Standard clinical care procedures and outcome measurements.', 'type': 'OTHER', 'description': 'Standard of care surgical interventions, imaging impressions, laboratory results, and outcome measurements will be collected and analyzed.', 'armGroupLabels': ['Control group', 'DCM group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Francis Farhadi, MD, PhD', 'role': 'CONTACT', 'email': 'francis.farhadi@uky.edu', 'phone': '859-562-0247'}, {'name': 'Jaimie Hixson, BS', 'role': 'CONTACT', 'email': 'jlhend3@uky.edu', 'phone': '859-323-1908'}], 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'centralContacts': [{'name': 'Francis Farhadi, MD, PhD', 'role': 'CONTACT', 'email': 'francis.farhadi@uky.edu', 'phone': '859-562-0247'}, {'name': 'Jaimie Hixson', 'role': 'CONTACT', 'email': 'jaimie.henderson@uky.edu', 'phone': '859-323-1908'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kentucky', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Francis Farhadi', 'investigatorAffiliation': 'University of Kentucky'}}}}