NCT07641699

Brief Summary

This is a multicenter, prospective, longitudinal, observational registry-based study of degenerative cervical myelopathy (DCM) across the full disease spectrum, linked to a disease-specific biobank. The study will enroll adults with non-myelopathic degenerative cervical cord compression, including asymptomatic degenerative cervical cord compression with or without radiculopathy, as well as patients with mild, moderate, or severe DCM. The study does not assign treatment or interfere with real-world clinical decision-making. All participants will undergo standardized baseline assessment, scheduled follow-up, and event-driven supplemental data collection. Core data include demographic information, comorbidities, disease characteristics, neurological examination, objective functional tests, patient-reported outcomes, cervical MRI findings, treatment pathway, treatment changes, adverse events, and long-term clinical outcomes. In participating centers, standardized biospecimen collection will be performed to support nested biomarker, immune, imaging, electrophysiological, and traditional Chinese medicine syndrome substudies. The main objective is to establish a standardized multicenter registry platform covering non-myelopathic degenerative cervical cord compression and mild, moderate, and severe DCM; to describe clinical trajectories, imaging evolution, treatment pathways, and long-term outcomes; and to identify factors associated with disease deterioration and functional prognosis.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
66mo left

Started Jun 2026

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Jun 2026Dec 2031

First Submitted

Initial submission to the registry

May 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2031

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

5.6 years

First QC Date

May 30, 2026

Last Update Submit

June 7, 2026

Conditions

Degenerative Cervical MyelopathyNon-myelopathic Degenerative Cervical Cord CompressionAsymptomatic Degenerative Cervical Cord CompressionCervical Spinal Cord Compression

Keywords

Degenerative cervical myelopathyDCMNon-myelopathic degenerative cervical cord compressionNMDCCCAsymptomatic degenerative cervical cord compressionADCCCervical spinal cord compressionCervical spondylotic myelopathyPatient registryBiobankNatural historyDisease progressionmJOACervical MRIDiffusion tensor imagingT2 mappingBlood biomarkerTraditional Chinese medicine syndrome

Outcome Measures

Primary Outcomes (1)

  • Time to First Composite Clinical Deterioration or Disease Progression Event

    This outcome will be reported as the time from baseline to the first occurrence of any component of the predefined composite clinical deterioration or disease progression endpoint. The composite endpoint is considered to have occurred when a participant first experiences one or more of the following events: progression from non-myelopathic degenerative cervical cord compression to clinical degenerative cervical myelopathy, a decrease in mJOA score of at least 2 points from baseline; a new clinically meaningful neurological deficit or definite myelopathic sign; predefined worsening in symptom/function state; treatment escalation due to objective disease progression; new sphincter dysfunction; loss of independent ambulation; or another major functional event adjudicated by investigators. Participants without any component event will be censored at the last available follow-up. The unit of measure is months from baseline to the first composite event.

    Baseline to 36 months

Secondary Outcomes (8)

  • Time to First Treatment Pathway Conversion

    Baseline to 36 months

  • Time to First Cervical Spine Surgery During Follow-up

    Baseline to 36 months

  • Time to First DCM-related Readmission

    Baseline to 36 months

  • Time to First Cervical Spine Reoperation or Additional Cervical Intervention

    Baseline to 36 months

  • Time to First Composite Major Functional Deterioration Event

    Baseline to 36 months

  • +3 more secondary outcomes

Other Outcomes (17)

  • Change From Baseline in mJOA Score

    Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months

  • Change From Baseline in JOA Score

    Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months

  • Change From Baseline in Nurick Grade

    Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months

  • +14 more other outcomes

Study Arms (5)

A1: Non-myelopathic Degenerative Cervical Cord Compression Without Radiculopathy

Adults with MRI-confirmed non-myelopathic degenerative cervical cord compression without clinical radiculopathy.

Other: Registry-based observation

A2: Non-myelopathic Degenerative Cervical Cord Compression With Radiculopathy

Adults with MRI-confirmed non-myelopathic degenerative cervical cord compression with clinical radiculopathy.

Other: Registry-based observation

B1: Mild Degenerative Cervical Myelopathy

Adults with clinically and radiologically confirmed degenerative cervical myelopathy with mild neurological impairment, defined as mJOA score 15-17.

Other: Registry-based observation

B2: Moderate Degenerative Cervical Myelopathy

Adults with clinically and radiologically confirmed degenerative cervical myelopathy with moderate neurological impairment, defined as mJOA score 12-14.

Other: Registry-based observation

B3: Severe Degenerative Cervical Myelopathy

Adults with clinically and radiologically confirmed degenerative cervical myelopathy with severe neurological impairment, defined as mJOA score 0-11.

Other: Registry-based observation

Interventions

Registry-based observationOTHER

Participants will receive routine clinical care according to real-world clinical decision-making. The study does not assign or mandate surgical or nonsurgical treatment. Clinical data, imaging data, follow-up outcomes, adverse events, and biospecimens will be collected according to the registry protocol.

A1: Non-myelopathic Degenerative Cervical Cord Compression Without RadiculopathyA2: Non-myelopathic Degenerative Cervical Cord Compression With RadiculopathyB1: Mild Degenerative Cervical MyelopathyB2: Moderate Degenerative Cervical MyelopathyB3: Severe Degenerative Cervical Myelopathy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults with MRI-confirmed degenerative cervical spinal cord compression caused by degenerative pathology will be enrolled from spine outpatient clinics, inpatient wards, preoperative assessment pathways, postoperative follow-up, and imaging review pathways. The study population includes non-myelopathic degenerative cervical cord compression, with or without radiculopathy, and clinically and radiologically confirmed mild, moderate, or severe degenerative cervical myelopathy. All participants must be able to complete baseline core assessments, provide written informed consent, and participate in longitudinal follow-up.

You may qualify if:

  • Age 18 years or older.
  • Cervical MRI confirms cervical spinal cord compression caused by degenerative pathology, including but not limited to disc protrusion or bulging, osteophyte formation, ligamentum flavum hypertrophy or ossification, ossification of the posterior longitudinal ligament, degenerative cervical canal stenosis, or other degenerative compressive factors.
  • At least one cervical level meets one or more of the following imaging criteria: partial or complete disappearance of the cerebrospinal fluid space around the spinal cord, direct contact between the spinal cord and degenerative compressive structures, focal spinal cord indentation, flattening or deformation, or other recognized imaging manifestations of degenerative cervical cord compression.
  • Meets one of the following clinical phenotypes: non-myelopathic degenerative cervical cord compression, with or without clinical radiculopathy; or clinically and radiologically confirmed mild, moderate, or severe degenerative cervical myelopathy.
  • Able to complete baseline core assessments and willing to participate in longitudinal follow-up.
  • Provides written informed consent. Additional consent may be obtained for specific biospecimen types or nested substudies.

You may not qualify if:

  • Cervical spinal cord compression or myelopathy mainly caused by non-degenerative etiologies, such as acute trauma, tumor, infection, inflammatory or demyelinating disease, vascular lesion, obvious congenital malformation, or other non-degenerative spinal cord disease.
  • Presence of a dominant other neurological disease or severe psychiatric or cognitive disorder that, in the investigator's judgment, would clearly interfere with DCM-related neurological functional assessment or make reliable follow-up impossible.
  • Refusal to sign informed consent or explicit refusal of core data collection and follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wangjing Hospital, China Academy of Chinese Medical Sciences

Beijing, Beijing Municipality, 100102, China

Location

Related Publications (4)

  • Bednarik J, Kadanka Z, Dusek L, Novotny O, Surelova D, Urbanek I, Prokes B. Presymptomatic spondylotic cervical cord compression. Spine (Phila Pa 1976). 2004 Oct 15;29(20):2260-9. doi: 10.1097/01.brs.0000142434.02579.84.

    PMID: 15480138RESULT

  • Yanez Touzet A, Bhatti A, Dohle E, Bhatti F, Lee KS, Furlan JC, Fehlings MG, Harrop JS, Zipser CM, Rodrigues-Pinto R, Milligan J, Sarewitz E, Curt A, Rahimi-Movaghar V, Aarabi B, Boerger TF, Tetreault L, Chen R, Guest JD, Kalsi-Ryan S, McNair AG, Kotter M, Davies B; AO Spine RECODE-DCM Steering Committee. Clinical outcome measures and their evidence base in degenerative cervical myelopathy: a systematic review to inform a core measurement set (AO Spine RECODE-DCM). BMJ Open. 2022 Jan 19;12(1):e057650. doi: 10.1136/bmjopen-2021-057650.

    PMID: 35046007RESULT

  • Davies BM, Yang X, Khan DZ, Mowforth OD, Touzet AY, Nouri A, Harrop JS, Aarabi B, Rahimi-Movaghar V, Kurpad SN, Guest JD, Tetreault L, Kwon BK, Boerger TF, Rodrigues-Pinto R, Furlan JC, Chen R, Zipser CM, Curt A, Milligan J, Kalsi-Rayn S, Sarewitz E, Sadler I, Blizzard T, Treanor C, Anderson D, Fallah N, Hazenbiller O, Salzman C, Zimmerman Z, Wandycz AM, Widdop S, Reeves M, Raine R, Ryan SK, Malone A, Gharooni A, Wilson JR, Martin AR, Fehlings MG, McNair AGK, Kotter MRN; AO SPINE RECODE-DCM Steering Committee and AO Spine RECODE DCM Community. A minimum data set-Core outcome set, core data elements, and core measurement set-For degenerative cervical myelopathy research (AO Spine RECODE DCM): A consensus study. PLoS Med. 2024 Aug 22;21(8):e1004447. doi: 10.1371/journal.pmed.1004447. eCollection 2024 Aug.

    PMID: 39173109RESULT

  • Fehlings MG, Tetreault LA, Riew KD, Middleton JW, Aarabi B, Arnold PM, Brodke DS, Burns AS, Carette S, Chen R, Chiba K, Dettori JR, Furlan JC, Harrop JS, Holly LT, Kalsi-Ryan S, Kotter M, Kwon BK, Martin AR, Milligan J, Nakashima H, Nagoshi N, Rhee J, Singh A, Skelly AC, Sodhi S, Wilson JR, Yee A, Wang JC. A Clinical Practice Guideline for the Management of Patients With Degenerative Cervical Myelopathy: Recommendations for Patients With Mild, Moderate, and Severe Disease and Nonmyelopathic Patients With Evidence of Cord Compression. Global Spine J. 2017 Sep;7(3 Suppl):70S-83S. doi: 10.1177/2192568217701914. Epub 2017 Sep 5.

    PMID: 29164035RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected and stored in a disease-specific biobank according to standardized procedures. The core blood collection protocol includes serum, EDTA plasma, buffy coat, and whole blood for complete blood count and correction variables. In selected immune or omics subcohorts, additional heparinized blood may be collected for PBMC isolation and storage. Optional surgically obtained tissues may be retained only with additional consent and ethics approval. Core biomarkers include NfL, IL-6, and BDNF, with hs-CRP, complete blood count, platelet count, creatinine, and eGFR used as correction or adjustment variables. Additional exploratory biomarkers may be assessed depending on funding, ethics approval, assay validation, sample availability, and biobank governance requirements.

MeSH Terms

Conditions

Disease Progression

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Liguo Zhu

    Wangjing Hospital, China Academy of Chinese Medical Sciences

    STUDY CHAIR

  • He Yin

    Wangjing Hospital, China Academy of Chinese Medical Sciences

    STUDY DIRECTOR

Central Study Contacts

He Yin

CONTACT

+8615901123675milkywaymoon@163.com

Bo Xu

CONTACT

+8615537762669xb202212@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
36 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2026

First Posted

June 11, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

December 31, 2031

Study Completion (Estimated)

December 31, 2031

Last Updated

June 11, 2026

Record last verified: 2026-06

Locations

CN(1)