NCT07183020Enrolling by invitation
Kappa Free Light Chains (KFLC) in Multiple Sclerosis (MS) and Clinically Isolated Syndrome (CIS)
Prospective, Multicentric, Real-world Investigation of Kappa Free Light Chains (KFLC) in Multiple Sclerosis (MS) and Clinically Isolated Syndrome (CIS)
Source: ClinicalTrials.gov · Last updated 19 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this observational study is to learn about the role of kappa free light chains (KFLC) in cerebrospinal fluid (CSF) in the diagnosis of multiple sclerosis (MS) and clinically isolated syndrome (CIS). The main question it aims to answer is: Are KFLC superior, inferior or equally useful in the diagnostic work-up of CSF of patients with MS and CIS? In CSF and serum sample pairs of patients diagnosed with MS or CIS, KFLC are measured using a nephelometric assay and are compared with the gold standard, of CSF diagnostics, oligoclonal bands.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 1142 (estimated)
- First submitted
- 10 Sept 2025
- Start date
- 27 Oct 2022
- Primary completion date
- 31 Jul 2026
- Lead sponsor
- Skripuletz, Thomas Prof. Dr.
- Diseases
- Multiple sclerosis
- NCT number
- NCT07183020
What you commit to
- Study type: Observational
- Planned participants: 1142
- From 27 Oct 2022 to the primary completion date, 31 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- no available cerebrospinal fluid (CSF) and serum sample pairs
Other
- no diagnosis of MS or CIS according to 2017-revised McDonald criteria for MS
Who the study is looking for
- patients diagnosed with multiple sclerosis (MS) or clinically isolated syndrome (CIS) according to 2017-revised McDonald criteria for MS
- age between 18 and 70 years
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Medizinische Hochschule Hannover / Hannover Medical School Coordinator of this site? Confirm its status | Hanover | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.