Prognostic Value of Three New Biomarkers of Multiple Sclerosis in Patients With Radiologically Isolated Syndrome

Multiple Sclerosis Clinical Trial

— T-RIS  

Official title:

Prognostic Value of Three New Biomarkers of Multiple Sclerosis Compared to Reference Biomarker in Patients With Radiologically Isolated Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03357887
• Other study ID #: NIMAO/2016/ET-01
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Radiologically Isolated Syndrome
• Sclerosis
• Syndrome

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