A Multicenter Registry-Based Study Across the Spectrum of Degenerative Cervical Myelopathy

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• Time to First Composite Clinical Deterioration or Disease Progression Event [Срок оценки: Baseline to 36 months]

Вторичные конечные точки (8)

• Time to First Treatment Pathway Conversion [Срок оценки: Baseline to 36 months]
• Time to First Cervical Spine Surgery During Follow-up [Срок оценки: Baseline to 36 months]
• Time to First DCM-related Readmission [Срок оценки: Baseline to 36 months]
• Time to First Cervical Spine Reoperation or Additional Cervical Intervention [Срок оценки: Baseline to 36 months]
• Time to First Composite Major Functional Deterioration Event [Срок оценки: Baseline to 36 months]
• Percentage of Participants With Serious Adverse Events [Срок оценки: Baseline to 36 months]
• Percentage of Surgically Treated Participants With Surgical Adverse Events [Срок оценки: From surgery to 36 months after baseline]
• Percentage of Participants With All-Cause Mortality [Срок оценки: Baseline to 36 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Wangjing Hospital, China Academy of Chinese Medical Sciences — Пекин

Публикации

• 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 15480138
• 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 syst PMID 35046007
• 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, Malon PMID 39173109
• 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 Myel PMID 29164035

Идентификаторы

NCT: NCT07641699 · 2024YFC3507401

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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