Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Regulation of Lipid Metabolism in Autoimmune Disease: Multiple Sclerosis (RELOAD-MS)

22. dubna 2020 aktualizováno: University College, London
The aim of this research is to understand how lipids such as cholesterol affect the disease process in people with MS.

Přehled studie

Postavení

Neznámý

Podmínky

Intervence / Léčba

Detailní popis

In Multiple Sclerosis (MS) immune cells recognise myelin, the coating around nerve fibres, as a foreign molecule and attack it by mistake; at the same time regulatory immune cells (which are normally protective) do not work properly and cannot block the harmful effects of the activated immune cells effectively.

Immune cells work via a complex system of signals that start on the outside layer of the cell (the plasma membrane), these signals are transmitted inside the cell where they trigger immune cell activation. The plasma membrane consists of a fatty layer and changes in the type of fat in the membrane can affect immune cell signalling and immune cell function.

The aims of this project are to:

  1. Identify what is different about the types of fat in immune cells from healthy donors and people with MS and identify what triggers the production of these different types of fat.
  2. Identify how different types of fat control immune cell function in healthy donors and people with MS
  3. Identify possible ways to regulate the type of fat in immune cell membranes to restore normal immune cell function in MS.

Methods: This research study involves collecting participant demographic and clinical information, blood and Cerebral Spinal Fluid (CSF) (optional) from patients with MS. Blood will also be collected from healthy volunteers for comparison. Experiments will be performed on the blood samples and the results correlated with the clinical and disease features of patients.

Outcomes: Many of the molecules involved in the generation of fats are well known and for some of them drugs are already used in humans to treat diseases (for example statins). This could allow the rapid translation of the results from this study to the clinic and have a direct impact for people with MS.

Typ studie

Pozorovací

Zápis (Očekávaný)

275

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Spojené království
      • London, Spojené království, NW1 2BU
        • Nábor
        • University College London Hospitals NHS Foundation Trust
        • Kontakt:
      • London, Spojené království, WC1N 3BG
        • Nábor
        • National Hospital For Neurology and Neurosurgery
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 80 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

Those with and those without MS

Popis

Inclusion Criteria:

  • 01. Male and female patients of between 18 years and 80 years of age with a diagnosis of MS or CIS.
  • Diagnosis confirmed according to the standards at the time when diagnosis was made.
  • Patients not receiving biological DMDs within the previous 3 months OR
  • Patients treated with DMDs (Interferon beta (Rebif, Betaferon, Avonex, Plegridy), Glatiramer Acetate (Copaxone), Dimethylfumarate (Tecfidera), Fingolimod (Gilenya), Teriflunomide (Aubagio), Natalizumab (Tysabri),) Alemtuzumab (Lemtrada), immunosuppressive drugs (azathioprine, cyclophosphamide etc) who have stable disease in the last 3 months.
  • Last course of corticosteroids more than three months ago.
  • 02. Having given written informed consent prior to undertaking any study-related procedures.
  • 03. Covered by a health insurance system where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research.
  • 04. Healthy donors ONLY : Male and female donors of between 18 years and 80 years of age in good health and not aware of any diagnosis of an autoimmune condition.

Exclusion Criteria:

  • 01. Patients currently taking statins or other lipid lowering therapies.
  • 02. Under any administrative or legal supervision.
  • 03. Conditions/situations such as:
  • Patients with conditions/concomitant diseases making them non evaluable for the primary endpoint
  • Impossibility to meet specific protocol requirements (e.g. blood sampling)
  • Patient is the Investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
  • Uncooperative or any condition that could make the patient potentially non-compliant to the study procedures
  • Pregnant or breast-feeding women, currently or in the last three months prior to inclusion
  • Patients who have been vaccinated in the last three months prior to inclusion

Healthy donors ONLY: will be excluded from the study if:

  • Donors with a condition likely to influence your blood results such as a current infection or cancer
  • Donors who are pregnant or breast-feeding currently or in the last three months
  • Donors who have been vaccinated within the last three months
  • Donors who cannot provide a blood sample
  • Donors who are unable to give informed consent

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
DMD treatment naive CIS or RRMS patients
Newly presenting Clinically Isolated Syndrome (CIS) or Relapsing and Remitting Multiple Sclerosis (RRMS) patients not treated before with Disease Modifying Drugs (DMD) Additional analysis of CSF and CSF cells will be performed in this cohort on a voluntary basis.
Jiný: Blood sampling
Blood sampling +/- CSF sampling
Ostatní jména:
  • CSF sampling
Secondary Progressive Multiple Sclerosis (SPMS)
People with confirmed diagnosis of SPMS
Jiný: Blood sampling
Blood sampling +/- CSF sampling
Ostatní jména:
  • CSF sampling
Primary Progressive Multiple Sclerosis (PPMS)
People with confirmed diagnosis of PPMS
Jiný: Blood sampling
Blood sampling +/- CSF sampling
Ostatní jména:
  • CSF sampling
DMD-treated with stable disease
People with Multiple Sclerosis (MS) who are treated with DMD who have had stable disease symptoms for at least 3 months
Jiný: Blood sampling
Blood sampling +/- CSF sampling
Ostatní jména:
  • CSF sampling
Disease controls
People who undergo lumbar puncture due to clinical suspicion of neurological condition, but brain Magnetic Resonance Imaging (MRI) and CSF examination exclude MS diagnosis.
Jiný: Blood sampling
Blood sampling +/- CSF sampling
Ostatní jména:
  • CSF sampling
Healthy donors
Age, sex and ethnicity matched healthy donors will also be recruited from university and hospital staff and patient friends after informed consent has been obtained. Healthy donors will be asked to provide a blood sample and demographic information but will NOT be asked to provide CSF samples.
Jiný: Blood sampling
Blood sampling +/- CSF sampling
Ostatní jména:
  • CSF sampling

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Lipid Phenotyping (1)
Časové okno: 4 hours from point of sample collection
Blood samples collected from consented participants containing the peripheral blood mononuclear cells (PBMC), serum, Deoxyribonucleic Acid (DNA) and CSF/CSF cells will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London (UCL), Rayne Building for lipid phenotyping of PBMC using flow cytometry
4 hours from point of sample collection
Lipid Phenotyping (2)
Časové okno: 4 hours from point of sample collection
Blood samples collected from consented participants containing the peripheral blood mononuclear cells (PBMC), serum, Deoxyribonucleic Acid (DNA) and CSF/CSF cells will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London, Rayne Building for lipid phenotyping of PBMC using measurement of quantitative polymerase chain reaction (qPCR)
4 hours from point of sample collection
Analysis of immune cell function
Časové okno: 4 hours from point of sample collection
Blood samples collected from consented participants containing the peripheral blood mononuclear cells (PBMC), serum, Deoxyribonucleic Acid (DNA) and CSF/CSF cells will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London, Rayne Building for analysis of immune cell function using flow cytometry.
4 hours from point of sample collection
Analysis of cytokine
Časové okno: 4 hours from point of sample collection
Blood samples collected from consented participants containing the peripheral blood mononuclear cells (PBMC), serum, Deoxyribonucleic Acid (DNA) and CSF/CSF cells will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London, Rayne Building for analysis of cytokine using flow cytometry.
4 hours from point of sample collection
Analysis of immune cell function (1)
Časové okno: 4 hours from point of sample collection
Blood samples collected from consented participants containing the peripheral blood mononuclear cells (PBMC), serum, Deoxyribonucleic Acid (DNA) and CSF/CSF cells will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London, Rayne Building for analysis of immune cell function through cell culture.
4 hours from point of sample collection
Analysis of immune cell function (2)
Časové okno: 4 hours from point of sample collection
Blood samples collected from consented participants containing the peripheral blood mononuclear cells (PBMC), serum, Deoxyribonucleic Acid (DNA) and CSF/CSF cells will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London, Rayne Building for analysis of immune cell function through flow cytometry.
4 hours from point of sample collection
Analysis of serum
Časové okno: 4 hours from point of sample collection
Blood samples collected from consented participants containing serum will be appropriately sent to Dr Elizabeth Jury, Centre for Rheumatology Research, University College London, Rayne Building for measurement of chemokine, lipid expression and expression of other molecules important for immune cell activation.
4 hours from point of sample collection

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University College, London

Spolupracovníci

University College London Hospitals

Vyšetřovatelé

  • Vrchní vyšetřovatel: Rachel Farrell, Dr, UCL & University College London Hospitals NHS Foundation Trust

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. září 2018

Primární dokončení (Očekávaný)

1. června 2020

Dokončení studie (Očekávaný)

1. června 2020

Termíny zápisu do studia

První předloženo

5. srpna 2019

První předloženo, které splnilo kritéria kontroly kvality

9. srpna 2019

První zveřejněno (Aktuální)

12. srpna 2019

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

24. dubna 2020

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

22. dubna 2020

Naposledy ověřeno

1. srpna 2019

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 18/0057

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NEROZHODNÝ

Popis plánu IPD

All participants indicate by written consent if they are willing to allow any of their un-used samples and associated data to be used for future research MS related research.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Předplatit