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OpenTrials
Completed

NCT Number: NCT04510350

Investigation of Novel Immunological Biomarkers by Mass Cytometry in Patients With Early Multiple Sclerosis (CISCO)

The objective of CISCO is therefore to identify prognostic biomarkers of MS activity in early-stage patients.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Rennes

Rennes, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Patients :

Inclusion criteria

  • Patients with clinically isolated syndrome (CIS) participating in the OFSEP cohort (French MS Observatory)
  • At least 18 years of age
  • Diagnosed with MS according to criteria 2017 at the time of their last visit.
  • Non-opposition to participation in the study
  • Having had at least one visit in the year following collection
  • Follow-up for at least 1 year after collection.
  • Having signed the OFSEP consent

Exclusion criteria

  • CIS patients with progressive MS

Healthy volunteers :

Inclusion criteria

  • Age 18 years or older
  • Having participated in the ABCD-SEP clinical trial promoted by the Rennes University Hospital (NCT03744351).
  • Matched on age and sex to patients of interest in the OFSEP cohort
  • Not having objected to participation in the study

Exclusion criteria

  • Persons of full age subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty

Treatment and study plan

biomarkers analysis

Other

Genetic analysis of regions of interest

Primary outcomes

  1. Frequency of immune subpopulations

    Time frame: 1 year

    Correlations between the frequency of immune subpopulations, genetic profile and disease activity

Secondary outcomes

  1. Frequency of immune subpopulations correlated to EDSS score

    Time frame: 1 year

    Correlations between the frequency of immune subpopulations, genetic profile, and EDSS score ((Expanded Disability Status Scale, method of quantifying disability in multiple sclerosis, steps 1.0 to 4.5 refer to people with MS who are fully ambulatory. EDSS steps 5.0 to 9.5 are defined by the impairment to ambulation.)

  2. Frequency of immune subpopulations correlated to disease progression delay

    Time frame: 1 year

    Correlations between the frequency of immune subpopulations, genetic profile, and delay before disease progression

  3. Frequency of immune subpopulations correlated to disease progression events

    Time frame: 1 year

    Correlations between the frequency of immune subpopulations, genetic profile, and number of disease progression events

  4. Frequency of immune subpopulations correlated to spinal lesions

    Time frame: 1 year

    Correlations between the frequency of immune subpopulations, genetic profile, and number of new spinal lesions

  5. Profiles of CIS+ patients

    Time frame: 1 year

    Comparison of genetic and immunological profiles of CIS+ patients with healthy volunteers

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: CISCO

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 12, 2020
Registry last updated
Mar 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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