Degenerative Cervical Myelopathy Repository (DCM)

Development of a Predictive Outcome Model for Patients With Degenerative Cervical Myelopathy Using Objective Functional and Biological Measures.

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.

Study Overview

• Status: Recruiting
• Conditions: Cervical Myelopathy
• Intervention / Treatment: Other: Standard clinical care procedures and outcome measurements.

• Study Type: Observational
• Enrollment (Estimated): 245

Contacts and Locations

• Study Contact: Name: Francis Farhadi, MD, PhD; Phone Number: 859-562-0247; Email: francis.farhadi@uky.edu
• Study Contact Backup: Name: Jaimie Hixson; Phone Number: 859-323-1908; Email: jaimie.henderson@uky.edu

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Recruiting
      • University of Kentucky
      • Contact: Francis Farhadi, MD, PhD; Phone Number: 859-562-0247; Email: francis.farhadi@uky.edu
      • Contact: Jaimie Hixson, BS; Phone Number: 859-323-1908; Email: jlhend3@uky.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• Diagnosis of degenerative cervical myelopathy
• Diagnosis of cervical degenerative disease without myelopathy

Exclusion Criteria:

• None outside or diagnostic requirements and age limits.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Data comparison between DCM and control groups	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.	2 years

Collaborators and Investigators

• Sponsor: University of Kentucky

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: July 1, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Hematologic Diseases; Spinal Cord Diseases; Bone Marrow Diseases
• Other Study ID Numbers: 78340

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No