Cervical Spondylotic MyelopathyNCT07772297
Biomarkers of Cervical Spondylotic Myelopathy
An observational study of Cervical Spondylotic Myelopathy, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cervical Spondylotic Myelopathy
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Sep 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
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.
- Malignancy
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Catherine Ravikumar, MS contact
United States1 site
UCSF Medical Center
San Francisco, California, 94143
Danielle Nieto, BA, 415-476-5199, danielle.nieto@ucsf.edu
Nima Alan, MD
About this study
Official title: Investigating -Omic Features and Prognostic Indicators of Cervical Spondylotic Myelopathy
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.
- Conditions
- Cervical Spondylotic Myelopathy
- Keywords
- Cervical Spondylotic Myelopathy, spine, Biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Preoperative/baseline visit
Secondary outcomes (3)
Association between serum RNA biomarkers and radiographic CSM severity
Measured: Preoperative/baseline visit
Association between serum RNA biomarkers and clinical CSM severity
CSM severity measured by clinical and sensorimotor examinations
Measured: Preoperative visit through 2 years postoperatively
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
Measured: Preoperative, 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cervical Spondylotic MyelopathyStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nima Alan, MD, Principal investigator, University of California San Francisco, Department of Neurological Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772297
- Sponsor's protocol ID
- 23-40300
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 19352222Nagata 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 22565382Nouri 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 25839387New 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating -Omic Features and Prognostic Indicators of Cervical Spondylotic Myelopathy
- ClinicalTrials.gov ID
- NCT07772297
- Acronym / sponsor ID
- 23-40300
- Conditions
- Cervical Spondylotic Myelopathy
- Keywords
- Cervical Spondylotic Myelopathy, spine, Biomarkers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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 is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
Association between serum RNA biomarkers and radiographic CSM severity
Time frame: Preoperative/baseline visit
Association between serum RNA biomarkers and clinical CSM severity
Time frame: Preoperative visit through 2 years postoperatively
Association between serum RNA biomarkers and functional outcomes/recovery
Time frame: Preoperative, 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Background: PubMed 19352222Rhee 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.
- Background: PubMed 22565382Nagata 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.
- Background: PubMed 25839387Nouri 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.
- Background: PubMed 23318556New 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Catherine Ravikumar, MS contact
Nima Alan, MD principal investigator
University of California San Francisco, Department of Neurological Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Spondylotic Myelopathy, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Danielle Nieto, BA (5102102469, danielle.nieto@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of serum RNA biomarkers for CSM (time frame: Preoperative/baseline visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07772297, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.