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A Multicenter Registry-Based Study Across the Spectrum of Degenerative Cervical Myelopathy (DCM-RB)

7. juni 2026 opdateret af: Wangjing Hospital, China Academy of Chinese Medical Sciences

A Multicenter Registry-Based Study of Degenerative Cervical Myelopathy Across the Full Disease Spectrum Based on a Disease-Specific Registry Platform and Linked Biobank

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Degenerative cervical myelopathy (DCM) is an important cause of chronic spinal cord dysfunction in adults. The disease spectrum includes non-myelopathic degenerative cervical cord compression, which may occur with or without radiculopathy, and clinically established mild, moderate, or severe DCM. Current clinical management and research increasingly require standardized longitudinal data collection across different disease stages, treatment pathways, imaging phenotypes, and functional states.

This study will establish a multicenter, prospective, longitudinal, observational registry based on a disease-specific registry platform and linked biobank. The study itself will not interfere with clinical treatment decisions. Participants will receive routine clinical care under real-world practice, including observation, nonsurgical treatment, surgery, or follow-up after previous cervical spine surgery as clinically indicated.

All enrolled participants will enter the same registry platform and undergo standardized baseline assessment, scheduled follow-up, and event-driven supplemental data collection. The registry will use a two-level data structure consisting of a core dataset and optional extended datasets. The core dataset includes demographic characteristics, comorbidities, disease history, neurological examination, objective functional tests, mJOA, JOA, Nurick grade, Neck Disability Index, SF-36v2, cervical MRI findings, treatment exposure, treatment changes, hospitalization, surgery, readmission, reoperation, adverse events, and major functional events.

Extended datasets may include quantitative MRI, diffusion tensor imaging, T2 mapping, electrophysiology, standardized blood biomarkers, PBMC-based immune profiling, omics assays, optional surgically obtained tissue, and structured traditional Chinese medicine syndrome assessment, depending on center capability, ethical approval, funding, and assay validation. The recommended core MRI protocol includes conventional cervical MRI, DTI, and T2 mapping. The core blood collection protocol includes serum, EDTA plasma, buffy coat, and whole blood for biomarker assays and correction variables.

Scheduled follow-up visits are planned at baseline, 3 months, 6 months, 12 months, 24 months, and 36 months, with extension to 60 months when feasible. Event-driven supplemental data collection will be performed when participants develop new myelopathic signs, clinically meaningful neurological deterioration, treatment escalation, surgery, readmission, reoperation, or other major functional events.

The primary endpoint is a composite endpoint of clinical deterioration or disease progression across the spectrum of degenerative cervical cord compression and DCM. The registry will support natural history research, clinical trajectory analysis, treatment pathway evaluation, biomarker exploration, nested prognostic modeling, and real-world outcome evaluation.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

200

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Beijing Municipality
      • Beijing, Beijing Municipality, Kina, 100102
        • Wangjing Hospital, China Academy of Chinese Medical Sciences
        • Kontakt:
        • Ledende efterforsker:
          • Liguo Zhu
        • Ledende efterforsker:
          • He Yin

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Objective inability to complete the core imaging assessment or core follow-up and judged by the investigator to be unsuitable for inclusion in the main registry cohort.
  • Refusal to sign informed consent or explicit refusal of core data collection and follow-up.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
A1: Non-myelopathic Degenerative Cervical Cord Compression Without Radiculopathy
Adults with MRI-confirmed non-myelopathic degenerative cervical cord compression without clinical radiculopathy.
Andet: Registry-based observation
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.
A2: Non-myelopathic Degenerative Cervical Cord Compression With Radiculopathy
Adults with MRI-confirmed non-myelopathic degenerative cervical cord compression with clinical radiculopathy.
Andet: Registry-based observation
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.
B1: Mild Degenerative Cervical Myelopathy
Adults with clinically and radiologically confirmed degenerative cervical myelopathy with mild neurological impairment, defined as mJOA score 15-17.
Andet: Registry-based observation
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.
B2: Moderate Degenerative Cervical Myelopathy
Adults with clinically and radiologically confirmed degenerative cervical myelopathy with moderate neurological impairment, defined as mJOA score 12-14.
Andet: Registry-based observation
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.
B3: Severe Degenerative Cervical Myelopathy
Adults with clinically and radiologically confirmed degenerative cervical myelopathy with severe neurological impairment, defined as mJOA score 0-11.
Andet: Registry-based observation
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to First Composite Clinical Deterioration or Disease Progression Event
Tidsramme: Baseline to 36 months
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to First Treatment Pathway Conversion
Tidsramme: Baseline to 36 months
This outcome will be reported as the time from baseline to the first treatment pathway conversion. Treatment pathway conversion is defined as a change from observation or regular follow-up to nonsurgical treatment, from observation or nonsurgical treatment to surgery, or another clinically justified treatment strategy change due to symptom worsening, neurological deterioration, imaging progression, or other objective disease progression. Participants without treatment pathway conversion will be censored at the last available follow-up. The unit of measure is months from baseline to first treatment pathway conversion.
Baseline to 36 months
Time to First Cervical Spine Surgery During Follow-up
Tidsramme: Baseline to 36 months
This outcome will be reported as the time from baseline to the first cervical spine surgery related to degenerative cervical cord compression or degenerative cervical myelopathy during follow-up. Cervical spine surgery includes cervical decompression, fusion, laminoplasty, or other DCM-related cervical surgical procedures. Participants without cervical spine surgery will be censored at the last available follow-up. The unit of measure is months from baseline to first cervical spine surgery.
Baseline to 36 months
Time to First DCM-related Readmission
Tidsramme: Baseline to 36 months
This outcome will be reported as the time from baseline to the first readmission related to degenerative cervical myelopathy, degenerative cervical cord compression, postoperative complications, disease recurrence, symptom aggravation, or other cervical spine-related causes. Participants without DCM-related readmission will be censored at the last available follow-up. The unit of measure is months from baseline to first DCM-related readmission.
Baseline to 36 months
Time to First Cervical Spine Reoperation or Additional Cervical Intervention
Tidsramme: Baseline to 36 months
This outcome will be reported as the time from baseline to the first cervical spine reoperation or additional cervical intervention related to degenerative cervical myelopathy, degenerative cervical cord compression, postoperative complications, disease recurrence, adjacent segment problems, or other cervical spine-related causes. Participants without reoperation or additional cervical intervention will be censored at the last available follow-up. The unit of measure is months from baseline to first reoperation or additional cervical intervention.
Baseline to 36 months
Time to First Composite Major Functional Deterioration Event
Tidsramme: Baseline to 36 months
This outcome will be reported as the time from baseline to the first occurrence of any component of the predefined composite major functional deterioration endpoint. The composite endpoint is considered to have occurred when a participant first experiences new or obviously worsened sphincter dysfunction, loss of independent ambulation, serious fall-related consequences, marked decline in activities of daily living, or another clinically meaningful major functional deterioration 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 first composite major functional deterioration event.
Baseline to 36 months
Percentage of Participants With Serious Adverse Events
Tidsramme: Baseline to 36 months
This outcome will be reported as the percentage of participants who experience at least one serious adverse event during follow-up. Serious adverse events include events resulting in death, life-threatening events, hospitalization or prolonged hospitalization, persistent or significant disability, or other medically important events. The unit of measure is the percentage of participants.
Baseline to 36 months
Percentage of Surgically Treated Participants With Surgical Adverse Events
Tidsramme: From surgery to 36 months after baseline
This outcome will be reported as the percentage of surgically treated participants who experience at least one surgical adverse event. Surgical adverse events may be recorded using SAVES-V2 or an equivalent structured adverse event recording tool when feasible. The unit of measure is percentage of surgically treated participants.
From surgery to 36 months after baseline
Percentage of Participants With All-Cause Mortality
Tidsramme: Baseline to 36 months
This outcome will be reported as the percentage of participants who die from any cause during follow-up. The date of death and main cause of death will be recorded when available. The unit of measure is the percentage of participants.
Baseline to 36 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change From Baseline in mJOA Score
Tidsramme: Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months
This outcome will be reported as the change from baseline in the modified Japanese Orthopaedic Association score at each scheduled follow-up visit. The mJOA score is a clinician-administered neurological function scale for degenerative cervical myelopathy. The unit of measure is points on the mJOA scale.
Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months
Change From Baseline in JOA Score
Tidsramme: Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months
This outcome will be reported as the change from baseline in the Japanese Orthopaedic Association score at each scheduled follow-up visit. The unit of measure is points on the JOA scale.
Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months
Change From Baseline in Nurick Grade
Tidsramme: Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months
This outcome will be reported as the change from baseline in Nurick grade at each scheduled follow-up visit. The Nurick grade is an ordinal clinician-rated measure of gait-related functional impairment in cervical myelopathy. The unit of measure is grade on the Nurick scale.
Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months
Change From Baseline in Neck Disability Index Score
Tidsramme: Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months
This outcome will be reported as the change from baseline in the Neck Disability Index score at each scheduled follow-up visit. The Neck Disability Index is a patient-reported questionnaire assessing neck-related disability. The unit of measure is points on the Neck Disability Index scale.
Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months
Change From Baseline in SF-36v2 Physical Component Summary Score
Tidsramme: Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months
This outcome will be reported as the change from baseline in the SF-36v2 Physical Component Summary score at each scheduled follow-up visit. The SF-36v2 is a patient-reported health-related quality of life questionnaire. The unit of measure is points on the SF-36v2 Physical Component Summary scale.
Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months
Change From Baseline in SF-36v2 Mental Component Summary Score
Tidsramme: Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months
This outcome will be reported as the change from baseline in the SF-36v2 Mental Component Summary score at each scheduled follow-up visit. The SF-36v2 is a patient-reported health-related quality of life questionnaire. The unit of measure is points on the SF-36v2 Mental Component Summary scale.
Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months
Change From Baseline in 10-Second Grip-and-Release Test Count
Tidsramme: Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months
This outcome will be reported as the change from baseline in the number of grip-and-release cycles completed within 10 seconds at each scheduled follow-up visit. The 10-second grip-and-release test is an objective hand function test. The unit of measure is the number of cycles.
Baseline, 3 months, 6 months, 12 months, 24 months, and 36 months
Change From Baseline in 10-Meter Walking Speed
Tidsramme: Baseline, 12 months, 24 months, and 36 months, or according to clinical follow-up availability
This outcome will be reported as the change from baseline in walking speed measured by the 10-meter walking test at each scheduled follow-up visit. The unit of measure is meters per second.
Baseline, 12 months, 24 months, and 36 months, or according to clinical follow-up availability
Change From Baseline in Maximum Spinal Cord Compression
Tidsramme: Baseline, 6 months, 12 months, 24 months, and 36 months
This outcome will be reported as the change from baseline in maximum spinal cord compression measured on cervical MRI. Maximum spinal cord compression will be assessed using offline quantitative MRI measurement. The unit of measure is percentage.
Baseline, 6 months, 12 months, 24 months, and 36 months
Change From Baseline in Maximum Canal Compromise
Tidsramme: Baseline, 12 months, 24 months, and 36 months
This outcome will be reported as the change from baseline in maximum canal compromise measured on cervical MRI. Maximum canal compromise will be assessed using offline quantitative MRI measurement. The unit of measure is percentage.
Baseline, 12 months, 24 months, and 36 months
Change From Baseline in Spinal Cord Cross-Sectional Area
Tidsramme: Baseline, 12 months, 24 months, and 36 months, when available
This outcome will be reported as the change from baseline in spinal cord cross-sectional area measured on cervical MRI at the target compression level. The unit of measure is square millimeters.
Baseline, 12 months, 24 months, and 36 months, when available
Change From Baseline in DTI Fractional Anisotropy
Tidsramme: Baseline, 12 months, 24 months, and 36 months
This outcome will be reported as the change from baseline in fractional anisotropy measured by cervical spinal cord diffusion tensor imaging at the target level or predefined region of interest. The unit of measure is fractional anisotropy value.
Baseline, 12 months, 24 months, and 36 months
Change From Baseline in T2 Mapping Value
Tidsramme: Baseline, 12 months, 24 months, and 36 months
This outcome will be reported as the change from baseline in cervical spinal cord T2 mapping value measured at the target level or predefined region of interest. The unit of measure is milliseconds.
Baseline, 12 months, 24 months, and 36 months
Change From Baseline in Plasma Neurofilament Light Chain Concentration
Tidsramme: Baseline, 6 months, 12 months, 24 months, and 36 months
This outcome will be reported as the change from baseline in plasma neurofilament light chain concentration measured in EDTA plasma. The measurement tool is a blood biomarker assay. The unit of measure is picograms per milliliter.
Baseline, 6 months, 12 months, 24 months, and 36 months
Change From Baseline in Serum Interleukin-6 Concentration
Tidsramme: Baseline, 6 months, 12 months, 24 months, and 36 months
This outcome will be reported as the change from baseline in serum interleukin-6 concentration measured in serum. The measurement tool is a blood biomarker assay. The unit of measure is picograms per milliliter.
Baseline, 6 months, 12 months, 24 months, and 36 months
Change From Baseline in Plasma Brain-Derived Neurotrophic Factor Concentration
Tidsramme: Baseline, 6 months, 12 months, 24 months, and 36 months
This outcome will be reported as the change from baseline in plasma brain-derived neurotrophic factor concentration measured in EDTA plasma. The measurement tool is a blood biomarker assay. The unit of measure is picograms per milliliter.
Baseline, 6 months, 12 months, 24 months, and 36 months
Time to First Worsening in Symptom and Functional State Category
Tidsramme: Baseline to 36 months
This outcome will be reported as the time from baseline to the first worsening in the predefined symptom and functional state category. Symptom and functional state will be classified by investigators using a predefined ordinal state category: S0, imaging compression without definite symptoms or signs; S1, radiculopathy-dominant state; S2, sensory-dominant state; S3, upper-limb motor or hand-function dominant state; S4, lower-limb or gait-dominant state; S5, mixed motor involvement; and S6, sphincter dysfunction or severe functional impairment. "Worsening" is defined as a transition to a higher severity state category. The unit of measure is months from baseline to the first worsening in the state category.
Baseline to 36 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Wangjing Hospital, China Academy of Chinese Medical Sciences

Samarbejdspartnere

Nanyang Hospital of Wangjing Hospital, China Academy of Chinese Medical Sciences

Efterforskere

  • Studiestol: Liguo Zhu, Wangjing Hospital, China Academy of Chinese Medical Sciences
  • Studieleder: He Yin, Wangjing Hospital, China Academy of Chinese Medical Sciences

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

31. december 2031

Studieafslutning (Anslået)

31. december 2031

Datoer for studieregistrering

Først indsendt

30. maj 2026

Først indsendt, der opfyldte QC-kriterier

7. juni 2026

Først opslået (Faktiske)

11. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

7. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2024YFC3507401

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

The individual participant data sharing plan has not yet been finalized. De-identified data may be made available for ethically approved collaborative research after completion of the main analyses, subject to institutional policies, ethics approval, data use agreements, and applicable regulations. Biospecimen access and transfer will require additional approval according to the biobank governance policy, ethics approval, sample management standard operating procedures, and material transfer agreements.

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