Biomarkers of Cervical Spondylotic Myelopathy

NCT07772297 | Not Yet Recruiting

• 1 other identifier: 23-40300
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Investigators believe that patients with cervical spondylotic myelopathy (CSM) have measurable changes in certain molecules in their blood compared with people without CSM. Investigators expect that these changes may be related to how severe a patient's condition is based on imaging and clinical exams. Investigators will also study how these molecules change before and after surgery to see whether they are related to how well patients recover. By combining these blood markers with clinical and imaging information, investigators hope to develop a tool that may help predict patient outcomes.

Conditions

Cervical Spondylotic Myelopathy

Keywords

Cervical Spondylotic Myelopathy; spine; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of serum RNA biomarkers for CSM

  Area under the receiver operating characteristic curve (AUC) comparing serum RNA biomarker levels in patients with CSM versus healthy controls

  Preoperative/baseline visit

Secondary Outcomes (3)

• Association between serum RNA biomarkers and radiographic CSM severity

  Preoperative/baseline visit

• Association between serum RNA biomarkers and clinical CSM severity

  Preoperative visit through 2 years postoperatively

• Association between serum RNA biomarkers and functional outcomes/recovery

  Preoperative, 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively

Other Outcomes (1)

• Longitudinal change in serum RNA biomarkers

  Preoperative, 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively

Study Arms (2)

CSM

All Adults over age of 18, with a diagnosis of/encompassed by/related to cervical spondylotic myelopathy, cervical myelopathy, or ossification of posterior longitudinal ligament.

Healthy, non-CSM

Adults over age of 18, with no neck pain, radiculopathy, or myelopathy symptoms, and no trauma in the past 6 months. Does not meet exclusion criteria.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include patients with cervical spondylotic myelopathy (CSM) receiving care at the UCSF Spine Center. Participants will undergo standard-of-care treatment and follow-up at UCSF, with research blood samples collected before surgery and at designated postoperative timepoints. Clinical, imaging, medical history, and patient-reported outcome data will also be collected throughout the study.

You may qualify if:

• Age \>18
• No neck pain
• No radiculopathy or myelopathy symptoms
• No trauma in the past 6 months

You may not qualify if:

• Age \>18
• Diagnosis of/encompassed by/related to cervical spondylotic myelopathy, cervical myelopathy, ossification of posterior longitudinal ligament.
• Age \<18.
• Malignancy
• Trauma in the past 6 months
• Infectious etiology
• Prior cervical spine surgery.
• Symptoms of cervical radiculopathy, myelopathy or neck pain.
• Age \<18.
• Malignancy
• Trauma in the past 6 months
• Infectious etiology.
• Prior cervical spine surgery.
• MRI or CT imaging demonstrating an alternative cause for cervical myelopathy that is not degenerative stenosis (i.e. transverse myelitis, tumor compressing cord, pathologic fracture).

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

UCSF Medical Center

San Francisco, California, 94143, United States

Location

Related Publications (4)

• Rhee JM, Heflin JA, Hamasaki T, Freedman B. Prevalence of physical signs in cervical myelopathy: a prospective, controlled study. Spine (Phila Pa 1976). 2009 Apr 20;34(9):890-5. doi: 10.1097/BRS.0b013e31819c944b.

  PMID: 19352222 BACKGROUND

• Nagata K, Yoshimura N, Muraki S, Hashizume H, Ishimoto Y, Yamada H, Takiguchi N, Nakagawa Y, Oka H, Kawaguchi H, Nakamura K, Akune T, Yoshida M. Prevalence of cervical cord compression and its association with physical performance in a population-based cohort in Japan: the Wakayama Spine Study. Spine (Phila Pa 1976). 2012 Oct 15;37(22):1892-8. doi: 10.1097/BRS.0b013e31825a2619.

  PMID: 22565382 BACKGROUND

• Nouri A, Tetreault L, Singh A, Karadimas SK, Fehlings MG. Degenerative Cervical Myelopathy: Epidemiology, Genetics, and Pathogenesis. Spine (Phila Pa 1976). 2015 Jun 15;40(12):E675-93. doi: 10.1097/BRS.0000000000000913.

  PMID: 25839387 BACKGROUND

• New PW, Cripps RA, Bonne Lee B. Global maps of non-traumatic spinal cord injury epidemiology: towards a living data repository. Spinal Cord. 2014 Feb;52(2):97-109. doi: 10.1038/sc.2012.165. Epub 2013 Jan 15.

  PMID: 23318556 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Investigators will use 1-2 cc of leftover blood from the sample collected at the patient's baseline, pre-operative visit according to standard of care procedures. Research specific procedures include obtaining additional postoperative 6 week, 3 month, 6 month, 12 month, and 24 month lab draws for blood testing. All postoperative draws will be 2 cc.

Study Officials

• Nima Alan, MD

  University of California San Francisco, Department of Neurological Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Danielle Nieto, BA

CONTACT

5102102469; danielle.nieto@ucsf.edu

Catherine Ravikumar, MS

CONTACT

catherine.ravikumar@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 19, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2030
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)