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NCT Number: NCT07772297

Biomarkers of Cervical Spondylotic Myelopathy

We believe that patients with cervical spondylotic myelopathy (CSM) have measurable changes in certain molecules in their blood compared with people without CSM. We expect that these changes may be related to how severe a patient's condition is based on imaging and clinical exams. We 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, we hope to develop a tool that may help predict patient outcomes.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UCSF Medical Center

San Francisco, California, 94143, United States

Location contact

Danielle Nieto, BA

CONTACT

[email protected]

415-476-5199

Ethan Winkler, MD, PhD

SUB_INVESTIGATOR

Jang Yoon, MD

SUB_INVESTIGATOR

Lee Tan, MD

SUB_INVESTIGATOR

Nima Alan, MD

PRINCIPAL_INVESTIGATOR

Praveen Mummaneni, MBA, MD

SUB_INVESTIGATOR

About this study

Cervical spondylotic myelopathy (CSM) represents the most common cause of non-traumatic spinal cord injury in adults (New et al., 2014) with an estimated prevalence of 605 per million in North America (Nouri et al., 2015). This degenerative condition leads to spinal cord compression which can result in severely debilitating symptoms such as weakness, loss of fine motor control, bowel and bladder dysfunction, and pain. Surgical decompression is often needed in patients with symptomatic neural element stenosis, and surgical decision-making is primarily based on clinical examination findings and imaging evidence of cervical spinal cord compression. However, the degree of spinal cord compression observed on imaging poorly correlates with the severity of neurologic dysfunction in cervical myelopathy patients (Nagata et al., 2012; Rhee et al., 2009). Additionally, there are no reliable objective measures or prognostic factors to aid in assessing patients best-suited for surgical decompression and recovery following surgery. This study aims to identify serum biomarkers of CSM injury severity and long-term outcomes. Our proposal focuses on transcriptomic changes as well as radiographic and clinical data variables in CSM patients to characterize RNA biomarkers of injury and recovery, which has been studied to date. Identification of prognostic biomarkers of CSM may uncover new mechanisms underlying spinal cord injury and develop predictive algorithms for CSM treatment planning and prediction of long-term outcomes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Healthy Inclusion Criteria: Adults over age of 18. No neck pain, radiculopathy, or myelopathy symptoms. No trauma in the past 6 months. Does not meet exclusion criteria.

CSM Inclusion Criteria: All Adults over age of 18. Diagnosis of/encompassed by/related to cervical spondylotic myelopathy, cervical myelopathy, ossification of posterior longitudinal ligament.

Exclusion criteria

Age <18. Malignancy, trauma in the past 6 months, infectious etiology, prior cervical surgery. Symptoms of cervical radiculopathy, myelopathy or neck pain.

CSM Exclusion Criteria: Age <18. Malignancy, trauma in the past 6 months, infectious etiology, prior cervical 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).

Treatment and study plan

Primary outcomes

  1. Diagnostic performance of serum RNA biomarkers for CSM

    Time frame: Preoperative/baseline visit

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

Secondary outcomes

  1. Association between serum RNA biomarkers and radiographic CSM severity

    Time frame: Preoperative/baseline visit

  2. Association between serum RNA biomarkers and clinical CSM severity

    Time frame: Preoperative visit through 2 years postoperatively

    CSM severity measured by clinical and sensorimotor examinations

  3. Association between serum RNA biomarkers and functional outcomes/recovery

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

    Association between changes in candidate serum RNA biomarker levels and postoperative functional outcomes, including study questionnaires and sensorimotor examinations

Other outcomes

  1. Longitudinal change in serum RNA biomarkers

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

Study contacts

Contact information is provided by the study sponsor or research team.

Catherine Ravikumar, MS

CONTACT

[email protected]

Danielle Nieto, BA

CONTACT

[email protected]

5102102469

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Investigating -Omic Features and Prognostic Indicators of Cervical Spondylotic Myelopathy

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Aug 19, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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