Asymptomatic Degenerative Cervical Cord Compression, Cervical Spinal Cord Compression, Degenerative Cervical Myelopathy, Non-myelopathic Degenerative Cervical Cord Compression
Conditions
Keywords
Degenerative cervical myelopathy, DCM, Non-myelopathic degenerative cervical cord compression, NMDCCC, Asymptomatic degenerative cervical cord compression, ADCC, Cervical spinal cord compression, Cervical spondylotic myelopathy, Patient registry, Biobank, Natural history, Disease progression, mJOA, Cervical MRI, Diffusion tensor imaging, T2 mapping, Blood biomarker, Traditional Chinese medicine syndrome
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.
Detailed description
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.
Interventions
OTHERRegistry-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.
Sponsors
Wangjing Hospital, China Academy of Chinese Medical Sciences
Nanyang Hospital of Wangjing Hospital, China Academy of Chinese Medical Sciences
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Composite Clinical Deterioration or Disease Progression Event | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Treatment Pathway Conversion | 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. |
| Time to First Cervical Spine Surgery During Follow-up | 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. |
| Time to First DCM-related Readmission | 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. |
| Time to First Cervical Spine Reoperation or Additional Cervical Intervention | 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. |
| Time to First Composite Major Functional Deterioration Event | 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. |
| Percentage of Participants With Serious Adverse Events | 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. |
| Percentage of Surgically Treated Participants With Surgical Adverse Events | 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. |
| Percentage of Participants With All-Cause Mortality | 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. |
Countries
China
Contacts
CONTACTHe Yin
CONTACTBo Xu
STUDY_CHAIRLiguo Zhu
Wangjing Hospital, China Academy of Chinese Medical Sciences
STUDY_DIRECTORHe Yin
Wangjing Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed