Badanie kliniczne dotyczące Stwardnienie rozsiane - Rejestr badań klinicznych

Przegląd badań

Status

Zakończony

Warunki

Stwardnienie rozsiane

Szczegółowy opis

Multiple sclerosis (MS) is a chronic inflammatory demyelinating disease of the Central Nervous System (CNS) affecting mostly young adults between 20 and 40 years of age. This disease is the leading cause of non-traumatic disability in young adults.

MS has long been considered a predominantly T-cell mediated disease. However, the remarkable efficacy of anti-CD20 monoclonal antibodies in this disease has demonstrated the major role of B-cell in the pathophysiology of this disease.

The B-cell have many functions: these cells are indeed able to secrete cytokines (pro and anti inflammatory), to present antigens to T lymphocytes, but also to differentiate into plasmocytic cells and thus to secrete immunoglobulins. Several studies have shown that B-cell in patients with MS secrete significantly more pro-inflammatory cytokines (GM-CSF, IL-6, TNFα). In addition, infiltrates and tertiary lymphoid structures have been found in the meninges of patients with MS, particularly in progressive forms of the disease. It seems clear to this day that these cells are strongly involved in the development of MS. Despite the many advances made recently in understanding the role of B-cell in the pathophysiology of MS, the precise involvement of plasma cells and their functions at different stages of the disease remains unclear.

Folluclar helper T cells (TFH) play a crucial role in lymphocyte B differentiation. These cells are located within the germinal centers in the secondary lymphoid organs, and their memory compartment also circulates in the blood. Several circulating TFH subpopulations have recently been defined, with different "helping" capacities.

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.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

90

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

Francja
- - Rennes, Francja, 35033
    - Rennes University Hospital

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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

Opis

Inclusion Criteria:

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...);
Patients with PL for diagnostic or surveillance purposes;
No immunomodulatory or immunosuppressive therapy for at least 3 months;
Free, informed and written consent signed by the patient.

Regarding healthy volunteers:

Adult (age greater than or equal to 18 years) of both sexes;
Free, informed and written consent signed by the volunteer.

Exclusion Criteria:

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Opis środka	Ramy czasowe
To compare the transcriptome profile of infiltrating TFH cells from CIS patients to non-MS patients with neurological inflammatory diseases Ramy czasowe: At inclusion	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

Miary wyników drugorzędnych

Miara wyniku	Opis środka	Ramy czasowe
To compare the transcriptome profile of infiltrating TFH cells from CIS patients to healthy volunteers. Ramy czasowe: At inclusion	Comparison of each gene expression of infiltrating TFH cells from CIS patients to those of healthy volunteers (HV) by RNAsequencing	At inclusion
To compare the B cell differentiation helping abilities of TFH cells from MS patients to those of HV Ramy czasowe: At inclusion	Analysis of B cell phenotype after 7 days of in vitro coculture assays and comparison of the frequencies between MS patients and HV	At inclusion
To compare the migration abilities of TFH cells from MS patients to those of HV Ramy czasowe: At inclusion	Analysis of the rate, number and phenotype of migrating TFH cells after 12 to 24 hours using an in vitro model of Blood Brain Barrier in MS patients compared to HV	At inclusion

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Rennes University Hospital

Śledczy

Główny śledczy: Laure Michel, Rennes University Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

25 lutego 2019

Zakończenie podstawowe (Rzeczywisty)

31 października 2021

Ukończenie studiów (Rzeczywisty)

31 października 2021

Daty rejestracji na studia

Pierwszy przesłany

13 stycznia 2020

Pierwszy przesłany, który spełnia kryteria kontroli jakości