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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03357887
Other study ID # NIMAO/2016/ET-01
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 1, 2018
Est. completion date December 31, 2018

Study information

Verified date December 2020
Source Centre Hospitalier Universitaire de Nimes
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To look at the prognostic value of new biomarkers in CSF and serum for characterisation of multiple sclerosis


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date December 31, 2018
Est. primary completion date December 31, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion criteria - Patients have given their free consent for use of their samples in research - Patients have at least 2 years of clinical and radiological follow-up data available Exclusion criterion - No follow-up of patients

Study Design


Intervention

Other:
Analysis of cerebrospinal fluid and serum
Analysis of biomarkers in patient biological samples

Locations

Country Name City State
France CHU Nimes Nîmes

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Level of tumour necrosis factor receptor in cerebrospinal fluid ELISA Baseline
Primary Level of Neurofilament in cerebrospinal fluid ELISA Baseline
Primary Level of GFAP in cerebrospinal fluid ELISA Baseline
Primary Level of secreted glycoprotein in cerebrospinal fluid ELISA Baseline
Secondary Level of tumour necrosis factor receptor in serum ELISA Baseline
Secondary Level of Neurofilament in serum ELISA Baseline
Secondary Level of GFAP in serum ELISA Baseline
Secondary Level of secreted glycoprotein in serum ELISA Baseline
Secondary Comparison of the conversion time according to the threshold value of each biomarker for Radiologically Isolated Syndrome patients Log-rank test Baseline
Secondary Compare prognostic value of all four markers of the high risk criteria (age below 37, male, myelitis). Multivariate analysis Baseline
Secondary Biomarker levels in CSF and serum in different patient subpopulations (Radiologically Isolated Syndrome, recurrent remittent MS, symptomatic controls, central nervous system inflammatory disease controls, non-inflammatory disease controls) Baseline
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