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Immunological and Virological Evaluation of ME/CFS

A Longitudinal Immunological and Virological Evaluation of Myalgic Encephalomyeltis/Chronic Fatigue Syndrome (ME/CFS) and the Establishment of a Research Resource for Prospective Studies

Specialty
PrimaryCare
Portfolio Eligibility
Automatically eligible
ISRCTN
EudraCT
MREC N°
UKCRN ID 12373
WHO ID
Research Summary
The causes and natural history of myalgic encephalopathy/chronic fatigue syndrome (ME/CFS) are poorly understood, although some virus infections and immune abnormalities have often been associated with ME/CFS. In the UK, biosamples from people with this condition have not been collected in a systematic way for research purposes. Building on our previous line of research (Nacul et al,2011; Phoeby et al, 2011; Lacerda et al, 2010), we propose: 1. to recruit and longitudinally assess a well characterized cohort of people with ME/CFS and population controls, frequency matched by geographical area of residence, age-group and sex; 2. to investigate the role and activity of known (such as herpes virus) and novel viruses in ME/CFS aetiology; 3. to investigate immunity in ME/CFS, including cytokine profile, absolute and functional alterations in NK cells and T cells, and how these vary in relation to the presence of markers of viral infection, gene expression and clinical phenotype; 4. to store blood samples of consenting individuals at the University College London/Royal Free Hospital Biobank, for future ethically approved studies on ME/CFS. It is hoped that these studies will enable the discovery of biomarkers associated with ME/CFS, which in time can be used therapeutically for diagnosis, and ultimately for assessing prognosis and treatment. We will invite people with ME/CFS, from the UK and from Latvia, to donate blood samples for the proposed studies, and future use by bona-fide researchers. Subjects without fatigue will be recruited as controls (frequency matched by age, sex, and area of residence). This project will be carried out within 40 months, and the blood samples will be stored in the biobank for up to 5 years, when they might be respectfully and securely discarded.
Study Type Observational
Design Type Cohort study
Disease(s) All Diseases
Phase N/A
Current Status Open
Closure Date 5/31/2016
Global Sample Size 510
Global Recruitment to Date
80%
Geographical Scope International Multi-Centre
Lead Country England
Open to new sites Yes, within lead country only
Main Inclusion Criteria
Cases – informed consent, age from 18 years to 60 years old, clinical diagnosis of ME/CFS, according to CDC-1994 (Fukuda, 1994) or Canadian (Carruthers, 2003) criteria. The diagnosis will be confirmed by a clinical researcher (research nurse or doctor) working for the study, who will consider the result of a range of laboratory tests aimed at excluding alternative diagnoses. Controls – informed consent , age from 18 years to 60 years old, no past or present fatiguing and/or other major morbidity, such as cancer and coronary heart disease.
Main Exclusion Criteria
Cases – Recent use (in the preceding 3 months) of drugs known to alter immune function (e.g. azathioprine, ciclosporin, methotrexate, steroids), anti-viral medications and vaccinations; history of acute and chronic infectious diseases such as hepatitis B and C, tuberculosis, HIV (but not herpes virus or other retrovirus infection); other severe illness and severe mood disorders. Controls – all of the above, in addition to the presence of any fatiguing illnesses and other conditions that would exclude a diagnosis of ME/CFS (in those with fatigue) present or past.
Chief Investigator(s)
Dr Luis Nacul
Further details, please contact
Dr Eliana Lacerda

London School of Hygiene and Tropical Medicine
Department of Epidemiology and Population Health
Keppel Street
London
WC1E 7HT
UNITED KINGDOM

Tel: 0208 958 8134
eliana.lacerda@lshtm.ac.uk
Funder(s) ME Research UK
Action for M.E.
ME Association
Sponsor(s)




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