Biomarkers of Cervical Spondylotic Myelopathy
ConditionCervical Spondylotic Myelopathy
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age >18
No neck pain
No radiculopathy or myelopathy symptoms
No trauma in the past 6 months
Disqualifiers
Age >18
Diagnosis of/encompassed by/related to cervical spondylotic myelopathy, cervical myelopathy, ossification of posterior longitudinal ligament.
Age <18.
Malignancy
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
50 Participants
are grouped into 2 trial groupsGroup A: CSM
Group B: Healthy, non-CSM
Trial outcomes
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 visitSecondary outcomes
1
Association between serum RNA biomarkers and radiographic CSM severity
Time frame
Preoperative/baseline visit2
Association between serum RNA biomarkers and clinical CSM severity
CSM severity measured by clinical and sensorimotor examinations
Time frame
Preoperative visit through 2 years postoperatively3
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 postoperativelyOther outcomes
1
Longitudinal change in serum RNA biomarkers
Time frame
Preoperative, 6 weeks, 3 months, 6 months, 1 year, and 2 years postoperativelySponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: