ClinicalTrials.gg
Not yet recruitingNCT07772297Updated Aug 20, 2026

Biomarkers of Cervical Spondylotic Myelopathy

An observational study in Cervical Spondylotic Myelopathy, sponsored by University of California, San Francisco. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-20.

Sponsored by University of California, San Francisco · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 85 studies in Spinal Cord Diseases with a site in United States — 29 open to participants now, 35 under way, 1 of them phase 3. Spinal Cord Diseases · United States.

Planned enrollment
10th of 14
50 · median 86
Started
2026
with 8 others
Observational
14 of 85
4 open now
Primary completion
2028-09
later than 29 of 34 live
Registered
84th of 85
by date

Among the 85 studies in Spinal Cord Diseases with a site in United States, this one is the 10th largest by planned enrollment of the 14 observational ones that give a count, is one of 9 that started in 2026, is one of 14 observational ones, reaches primary completion later than 29 of the 34 other live ones, and was the 84th registered.

Spinal Cord Diseases

170 studies on the registry are indexed under Spinal Cord Diseases; 56 are open to participants now.

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Open to participants now

29 of the 85 studies in Spinal Cord Diseases with a site in United States are open now. Recruiting first, the newest first:

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A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 32 Spinal Cord Diseases studies recruiting now, 18 (56%) set no upper age limit and 6 (19%) stop at 75 or younger; 2 take children under 18; 9 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

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02

Study 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.

Read the detailed description

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. This 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.

03

Conditions studied

  • Cervical Spondylotic Myelopathy

Browse trials for

Keywords

  • Cervical Spondylotic Myelopathy
  • spine
  • Biomarkers
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Eligibility criteria

Healthy Inclusion Criteria:

  • Age >18
  • No neck pain
  • No radiculopathy or myelopathy symptoms
  • No trauma in the past 6 months
  • Does not meet exclusion criteria.

CSM Inclusion Criteria:

  • Age >18
  • Diagnosis of/encompassed by/related to cervical spondylotic myelopathy, cervical myelopathy, ossification of posterior longitudinal ligament.

Healthy Exclusion Criteria:

  • Age \<18.
  • Trauma in the past 6 months
  • Infectious etiology
  • Prior cervical spine 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 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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

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

    Time frame: Preoperative/baseline visit

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

    CSM severity measured by clinical and sensorimotor examinations

    Time frame: Preoperative visit through 2 years postoperatively

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

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

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

Other outcomes

  1. Longitudinal change in serum RNA biomarkers

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

07

Study locations

1 site
  • UCSF Medical Center
    San Francisco, California 94143, United States
    • Danielle Nieto, BA · Contactdanielle.nieto@ucsf.edu · 415-476-5199
    • Nima Alan, MD · Principal investigator
    • Ethan Winkler, MD, PhD · Sub investigator
    • Lee Tan, MD · Sub investigator
    • Praveen Mummaneni, MBA, MD · Sub investigator
    • Jang Yoon, MD · Sub investigator
08

References and documents

Publications

  • 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. PubMed 19352222 ↗
  • 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. PubMed 22565382 ↗
  • 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. PubMed 25839387 ↗
  • 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. PubMed 23318556 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Sep 2028, 24 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 13, 2026
First posted
Aug 19, 2026
StartEst.
Sep 2026
Primary completionEst.
Sep 2028
CompletionEst.
Sep 2030
Last update
Aug 20, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07772297
Responsible party
Sponsor
First posted
Aug 19, 2026
Start date
Sep 2026 (estimated)
Primary completion
Sep 2028 (estimated)
Completion
Sep 2030 (estimated)
Last update
Aug 20, 2026

Study contacts

Danielle Nieto, BA
Contact
danielle.nieto@ucsf.edu
5102102469
Catherine Ravikumar, MS
Contact
catherine.ravikumar@ucsf.edu
Nima Alan, MD
principal investigator · University of California San Francisco, Department of Neurological Surgery

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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