NCT05056740 Combined Analysis of Inflammatory Biomarkers for CNS Autoimmune Diseases Diagnostic
| NCT ID | NCT05056740 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire de Nice |
| Condition | Central Nervous System Diseases |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2020-06-01 |
| Primary Completion | 2023-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2020-06-01 with a primary completion date of 2023-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Project rationale: Since 2017, multiple sclerosis diagnosis should match the new McDonald criteria in which a "no better explanation than MS" should be fulfilled. However, many patients present with red flags that lead to a complex diagnostic work-up. There are no available biomarkers that permit to confirm or roll out MS diagnosis in such cases. Therefore, we lack biological markers that can help in the diagnosis of patients presenting with suspected MS. Many studies have found that serum and cerebrospinal fluid (CSF) cytokines could help to differentiate MS from other diseases such as neuromyelitis optica spectrum disorders (i.e., IL-6) or neurosarcoidosis (i.e., sIL-2R). Serum and CSF kappa free light chains have also shown good diagnosis performance in MS. In daily practice, our MS tertiary center already perform the analysis of CSF concentrations of IL-1β, sIL-2R, IL-6, IL-10, and serum and CSF kappa and lambda free light chains to roll out other central nervous system (CNS) autoimmune diseases in patients presenting with white matter hyperintensities (WMH). Objective: To correlate CSF IL-1β, sIL-2R, IL-6, IL-10, serum and CSF kappa and lambda free light chains with the final diagnosis in patients presenting to our MS tertiary center with suspected MS to identify a specific inflammatory biomarker profil involved in MS and other CNS autoimmune diseases. The methodology: This is an observational study. All patients ongoing a routine diagnostic work-up for suspected MS from june 2020 to june 2022 in our MS tertiary center will be analyzed. Cerebrospinal fluid IL-1β, sIL-2R, IL-6, IL-10, serum and CSF kappa and lambda free light chains will be correlated with the final diagnosis to ultimately find MS associated biomarkers.
Eligibility Criteria
Inclusion Criteria: * Patients referred to our center for the diagnostic work-up of White Matter Lesions * Patients that need a routine blood analysis * Patients that need a routine CSF analysis * Non opposition to research consent Exclusion Criteria: * Patients with a contraindication to perform spinal tap (increase bleeding risk medicine or disease) * Patients with a contraindication to MRI (metal prosthesis…)
Frequently Asked Questions
Who can join the NCT05056740 clinical trial?
This trial is open to participants of all sexes, studying Central Nervous System Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05056740 currently recruiting?
Yes, NCT05056740 is actively recruiting participants. Visit ClinicalTrials.gov or contact Centre Hospitalier Universitaire de Nice to inquire about joining.
Where is the NCT05056740 trial being conducted?
This trial is being conducted at Nice, France.
Who is sponsoring the NCT05056740 clinical trial?
NCT05056740 is sponsored by Centre Hospitalier Universitaire de Nice. The trial plans to enroll 300 participants.