DCM: Degenerative Cervical Myelopathy Repository

• Sponsor: University of Kentucky (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05446259
• Collaborator: (none)
• Enrollment: 245
• Location: 1
• Anticipated Duration (Months): 69.6
• Patients Per Site Per Month: 3.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Myelopathy	Other: Standard clinical care procedures and outcome measurements.

Study Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 245 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Development of a Predictive Outcome Model for Patients With Degenerative Cervical Myelopathy Using Objective Functional and Biological Measures.
• Actual Study Start Date: Jul 13, 2022
• Anticipated Primary Completion Date: Jun 1, 2027
• Anticipated Study Completion Date: May 1, 2028

Arms and Interventions

Arm	Intervention/Treatment
DCM group Subjects diagnosed with degenerative cervical myelopathy.	Other: Standard clinical care procedures and outcome measurements.; Standard of care surgical interventions, imaging impressions, laboratory results, and outcome measurements will be collected and analyzed.
Control group Subjects diagnosed with cervical spinal disease without myelopathic symptoms.	Other: Standard clinical care procedures and outcome measurements.; Standard of care surgical interventions, imaging impressions, laboratory results, and outcome measurements will be collected and analyzed.

Outcome Measures

Primary Outcome Measures

1. Data comparison between DCM and control groups [2 years]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of degenerative cervical myelopathy

• Diagnosis of cervical degenerative disease without myelopathy

Exclusion Criteria:

• None outside or diagnostic requirements and age limits.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kentucky	Lexington	Kentucky	United States	40536

Sponsors and Collaborators

• University of Kentucky

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: H. Francis Farhadi, Associate Professor, University of Kentucky
• ClinicalTrials.gov Identifier: NCT05446259
• Other Study ID Numbers: 78340
• First Posted: Jul 6, 2022
• Last Update Posted: Jul 19, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Spinal Cord Diseases; Bone Marrow Diseases

Study Results

No Results Posted as of Jul 19, 2022