MUltiple Sclerosis : T Cell / B Cell Exploration

NCT04231253 | Completed

• 1 other identifier: 35RC19_8871_MUST-BE
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study, an ancillary to ABCD-SEP (NCT03744351), will be interested in more precisely characterizing circulating and infiltrating TH cells in Multiple Sclerosis whether at the transcriptomic level or at the functional level.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• To compare the transcriptome profile of infiltrating TFH cells from CIS patients to non-MS patients with neurological inflammatory diseases

  Comparison of each gene expression of infiltrating TFH cells from CIS patients to those of non-MS patients with neurological inflammatory diseases by RNAsequencing

  At inclusion

Secondary Outcomes (3)

• To compare the transcriptome profile of infiltrating TFH cells from CIS patients to healthy volunteers.

  At inclusion

• To compare the B cell differentiation helping abilities of TFH cells from MS patients to those of HV

  At inclusion

• To compare the migration abilities of TFH cells from MS patients to those of HV

  At inclusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The population concerned is the same as the one participating in the ABCD-SEP study. These patients gave their consent for the remaining biological samples to be used for ulterior research

You may qualify if:

• Regarding MS patients (remitting or progressive untreated):
• Adult (age greater than or equal to 18 years) of both sexes;
• MS fulfilling the criteria of McDonald 2017;
• Remittent or progressive form;
• No immunomodulatory or immunosuppressive therapy for at least 3 months;
• Free, informed and written consent signed by the patient.
• Regarding Clinically Isolated Syndrome:
• Adult (age greater than or equal to 18 years) of both sexes;
• Clinically isolated syndrome suggestive of MS (at least two typical lesions in two different locations);
• Patient receiving a Lumbar Puncture (PL) for diagnostic purposes;
• No immunomodulatory or immunosuppressive therapy for at least 3 months;
• Free, informed and written consent signed by the patient.
• Regarding non-MS patients with neurological inflammatory disease:
• Adult (age greater than or equal to 18 years) of both sexes;
• Patient with non-MS neurological inflammatory disease (examples: meningitis, neurolupus, neurosarcoidosis...);

You may not qualify if:

• Regarding all patients:
• Pregnancy;
• Breastfeeding;
• Treatment with corticotherapy in the last month;
• Patient not affiliated to health insurance;
• Persons major subject to legal protection (safeguard of justice, guardianship, tutorship), persons deprived of their liberty.
• Regarding healthy volunteers:
• Pregnancy;
• Breastfeeding;
• Not affiliated to social security;
• Persons major subject to legal protection (safeguard of justice, guardianship, tutorship), persons deprived of their liberty.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (1)

Rennes University Hospital

Rennes, 35033, France

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Laure Michel

  Rennes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 18, 2020
• Study Start: February 25, 2019
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: December 2, 2021

Record last verified: 2021-12

Locations

FR (1)