NCT05446259

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
245

participants targeted

Target at P75+ for all trials

Timeline
24mo left

Started Jul 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress66%
Jul 2022May 2028

First Submitted

Initial submission to the registry

July 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 6, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

July 13, 2022

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

4.9 years

First QC Date

July 1, 2022

Last Update Submit

February 10, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

DCM group

Subjects diagnosed with degenerative cervical myelopathy.

Other: Standard clinical care procedures and outcome measurements.

Control group

Subjects diagnosed with cervical spinal disease without myelopathic symptoms.

Other: Standard clinical care procedures and outcome measurements.

Interventions

Standard of care surgical interventions, imaging impressions, laboratory results, and outcome measurements will be collected and analyzed.

Control groupDCM group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • None outside or diagnostic requirements and age limits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimens will be collected and banked for future IRB approved research studies.

Study Officials

  • Francis Farhadi, MD, PhD

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francis Farhadi, MD, PhD

CONTACT

Harshit Arora, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 1, 2022

First Posted

July 6, 2022

Study Start

July 13, 2022

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

May 1, 2028

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations