A Multicenter Registry-Based Study of Degenerative Cervical Myelopathy Across the Full Disease Spectrum Based on a Disease-Specific Registry Platform and Linked Biobank
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.