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UK ME/CFS biobank paves the way for faster, bigger and better research

Discussion in 'General ME/CFS News' started by Simon, Aug 11, 2016.

  1. Simon


    Monmouth, UK
    The UK ME/CFS biobank paves the way for bigger and better research | #MEAction
    a new blog

    On ME Awareness day this year, 12th May, the London School of Tropical Hygiene and Medicine (LSTHM) opened the UK ME/CFS Biobank for business, with blood samples available from 300 patients now, and there will soon be samples for over 200 controls. The ready availability of samples for large numbers of well-characterised patients and controls has the potential to make research faster, easier and better.

    Getting patients and samples can be the biggest hurdle in biomedical research
    Often the hardest, most expensive, slowest – and yet perhaps the most important – part of a research study is assembling samples from a group of well-diagnosed patients. The Biobank can jump-start the research process by providing ‘off the shelf’ patient samples that can be shipped anywhere in the world. Almost all the Biobank patients meet Canadian consensus criteria, and researchers can pick and choose samples according to criteria. Not only is this much faster and more convenient for researchers, it allows them access to large numbers of patients, which is critical in a field that has been plagued by small sample sizes and unreliable results.

    Enough blood to launch a wave of large studies
    Blood is processed into different sample types, such as plasma and white blood cells.

    The Biobank is big enough to potentially power a wave of new, large studies that would significantly change the research landscape. Size matters in research studies and bigger is better (for rather tedious statistical reasons). Big studies can detect smaller, but important, differences small studies would miss, as well as having the power to find subgroups – something incredibly important in ME research. Also, findings from small studies are also more likely to be false positives, and where they do find a real effect, it’s likely to be smaller than the study finds.

    To put the Biobank’s potential to enable bigger studies into perspective, the largest biomedical study in recent times is Dr Mady Hornig and Dr Ian Lipkin‘s cytokine signature study last year, with almost 300 patients. There are 300 patients in the UK ME/CFS Biobank, with 40 samples for each patient (and control) so it could power many studies this size. The Lipkin/Hornig study needed two samples for each person in the study and if that’s typical then the 40 samples for each Biobank subject could power twenty such studies, each with 300 patients. Or it could power 60 studies with 100 patients each, still large by current standards.

    Read the full blog at #MEAction
  2. aimossy

    aimossy Senior Member

    Seriously educational information in this @Simon thank you!
    rosie26, JaimeS, barbc56 and 3 others like this.
  3. lnester7

    lnester7 Seven

    How trustable is this bank when in the UK CFS is so physc, is the patient pool real?. Just a thought.
    *GG* likes this.
  4. charles shepherd

    charles shepherd Senior Member

    Re Participant Selection:

    People who volunteer to provide blood samples for the UK ME/CFS Biobank have an extremely thorough clinical assessment, examination and investigations to ensure that they meet diagnostic criteria (Canadian or CDC) for ME/CFS

    In the case of people with severe ME/CFS, this clinical assessment and sample taking is done in their own home

    We therefore have an enormous amount of clinical data (history; examination; blood test results) on each volunteer - so we can match samples to various diagnosic criteria for both ME and CFS

    For a detailed description on the patient selection process see pages 6 - 10 of the latest full Biobank report:

    Current participants:

    ME/CFS Biobank video:

    Report of the May 2016 meeting to announce that blood samples can now be requested by the research community:

    Dr Charles Shepherd
    Chairman, UK ME/CFS Biobank Steering Group
    Justin30, Simon, Cheshire and 7 others like this.
  5. worldbackwards

    worldbackwards Senior Member

    Not both then. Presumably this means that some idiopathic CF sufferers will get through?
  6. charles shepherd

    charles shepherd Senior Member


    Below is a fairly detailed description of the participant selection process - it is both time consuming and fairly costly to organise..

    Everyone who is eventually included in the ME/CFS Biobank, along with their blood samples, meets Canadian and/or CDC diagnostic criteria. Knowing which criteria people meet (and this can be extended to other diagnostic criteria) is clearly designed to help sub-grouping/clinical phenotyping under the ME/CFS umbrella.

    I'm not sure how you define idiopathic chronic fatigue but I hope it is now clear that we do NOT hold samples from people who fail to meet Canadian or CDC diagnostic criteria for ME/CFS.

    Participant recruitment

    Inclusion criteria

    ME/CFS cases: informed consent, 18 to 60 years old, and a clinical diagnosis of

    ME/CFS according to Canadian or CDC-1994 criteria. Compliance with study

    criteria is confirmed by a clinical member of the research team (doctor) after

    reviewing the results of a range of laboratory tests used to exclude alternative


    Healthy controls: informed consent, 18 to 60 years old, no past or present fatiguing

    illnesses and/or other major morbidity such as cancer or coronary heart disease.

    Exclusion criteria

    Cases: Recent use (in the preceding 3 months) of drugs known to alter immune

    function (e.g. azathioprine, cyclosporine, 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 illnesses and severe mood disorders. Pregnant women and

    those within 12 months post-partum and/or currently lactating are excluded.

    Healthy 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.

    Potential participants were invited to join the study by their doctor (affiliated with a

    collaborating NHS site) or by ME/CFS Disease Register staff if the patient was enrolled in

    the ME/CFS Disease Register. The LSHTM research team provide invitation packs to the

    participating NHS sites, which post them to the potential participants identified in the

    database search. The invitation pack included an invitation letter from the health service,

    information about the study (with separate information sheets for cases and controls), a

    “Symptoms Assessment” form for determining case definition compliance, a consent form, a

    refusal form, and a stamped self-addressed envelope.

    Because people severely affected by ME/CFS (that is, bed- or home-bound) often do not, or

    cannot, visit NHS services, and are particularly under-represented in ME/CFS research,

    information sheets and invitation packs were sent to support groups in the Greater London

    area for identification of and distribution to interested individuals in this segment of the

    ME/CFS population.

    Potential participants with ME/CFS were also asked to invite a friend to participate as a

    healthy control and so invitation packs were provided to them for this purpose. Additionally,

    information packs were made available at NHS sites and at LSHTM to supplement healthy

    control recruitment.

    When the signed consent and “Symptoms Assessment” forms are received by the

    research team, they are reviewed by the clinical researcher to confirm compliance with the

    inclusion and exclusion criteria for cases and controls. All potential cases would have

    received a diagnosis of ME/CFS at some time in the past. The clinical staff then assess

    the diagnosis of ME/CFS according to the study’s protocol, which requires compliance with

    the Canadian Consensus Criteria and/or the CDC-1994 criteria. Cases meeting the

    former have been shown in most cases to also meet the latter criteria, and the former

    seems to characterise those who are most severely affected. Comprehensive phenotyping of

    patients at baseline also enabled categorisation of individuals according to other clinical

    criteria, such as the London (ME) and International Consensus criteria, although these

    definitions were not used to determine enrolment eligibility.

    Once eligibility is established, the research team book appointments for participants for

    clinical assessments and blood sample collection. Participants in the Greater London area

    with severe disease and/or mobility restrictions are seen at their homes. Consenting

    respondents ineligible according to the screening questionnaire are thanked by the

    research team and told that their ineligibility was based on the exclusionary criteria.

    Clinical assessments & phlebotomy

    Clinical assessments include the following clinical measurements:

    • blood pressure and pulse taken at rest in seated and standing positions (both taken


    • hand grip strength test (three repeated 3-second measurements using the dominant


    • waist circumference;

    • standing height;

    • weight and bioimpedance (a measurement of body composition estimating body fat

    and lean body mass);

    • spirometry; and

    • pulse oximetry.

    Recruitment took place in the East of England and within Greater London. Baseline blood

    tests were carried out at the James Paget University Hospital in Great Yarmouth, the Royal

    Free Hospital in London, and the Norfolk and Norwich University Hospital (NNUH). Samples

    were transported to the UCL/RFH BioBank immediately after collection to ensure receipt by

    the BioBank within six hours of collection for processing, aliquoting, and storage.

    Baseline blood tests included a full blood count, blood chemistry, calcium, electrolytes,

    creatinine, serum creatine kinase, liver function tests, erythrocyte sedimentation rate, Creactive

    protein, rheumatoid factor, thyroid function tests, tissue transglutaminase

    antibodies, serum vitamin B12, and serum folate. Additionally, participants were asked at the

    time of the clinical assessment to produce a sample of urine to be screened for glucose,

    blood, protein, and specific gravity.

    The research team sent questionnaires to participants at the time of the blood collection

    covering demographic, socio-economic, and other exposure variables as well as clinical

    history, including information on illness onset and an extensive list of symptoms, family

    health history, and symptoms currently being experienced (at the time of the blood

    collection), which can all be linked to both the baseline laboratory tests and the de-identified

    blood samples. Questions were chosen taking into account the team’s experience with

    ME/CFS research and variables captured by the UK Biobank project.

    The following instruments were used to further characterise participants: Medical Outcomes

    Survey Short Form – SF-36v2 for assessment of functional capacity; the pain analogue

    scale for assessment of pain severity; a fatigue severity scale; the energy fatigue

    scale; a fatigue disability scale, based on the Karnofsky scale, the General Health

    Questionnaire – GHQ-28, and the Epworth sleepiness score.

    All participants meeting eligibility criteria are asked for blood samples (approximately

    95ml), from which approximately 15ml is used for baseline laboratory tests to exclude

    other diagnoses. The remainder is processed and stored at the UCL/RFH BioBank for

    future ethically-approved studies, including those planned by the LSHTM research team, for

    which participants have given “a priori” consent.

    The UCL/RFH BioBank, a state-of-the-science facility licensed by the Human Tissue

    Authority (Licence number 11016), which holds specific ethical approval for the processing

    and storage of biological samples. No personally-identifiable information is stored in the

    UCL/RFH BioBank database and so stored samples can be linked anonymously to a range

    of clinical and other non-identifiable data from participants.

    Further details on the collection, transport, processing, and storage of blood samples follow:

    • The LSHTM team prepare blood collection kits including the required number and

    type of Vacutainer tubes and a needle. SOPs for blood collection and transport ware


    • Staff members at the UCL/RFH BioBank follow SOPs for receipt, logging,

    processing, and storage of samples. The Vacutainer blood tubes received at the

    BioBank yielded aliquots of serum, plasma (from both NaHep and EDTA tubes),

    peripheral mononuclear blood cells, a red blood cell/granulocyte pellet, and whole

    blood, in addition to the PAXgene tube for RNA. The separated cells, plasma and

    serum samples can be used for a range of investigations and techniques, including

    for RNA and DNA extraction.

    • All samples can be stored at the UCL/RFH BioBank for up to five years in the first

    instance. Inventories of samples in the BioBank are sent regularly to the research

    JohnCB, lnester7, Simon and 5 others like this.
  7. simeyss


    Melbourne, Australia
    This is terrific! What a great boost to UK research initiatives. We need more biobanks. Thanks for this info, @Simon . :)
    aimossy, Simon, rosie26 and 2 others like this.
  8. Simon


    Monmouth, UK
    The UK certainly has a generous supply of BPS researchers, but not all UK researchers have that perspective, and certainly not the CURE-ME team. The £1m NIH grant that paid for a large expansion of the biobank also funded an immunology and virology study, which is currently in progress (and should be the first large study to emerge from the biobank).
    UK ME/CFS Biobank project awarded £1 million grant
    more detail: A longitudinal immunological and virological study for ME CFS biomarker discovery - Luis Nacul
    AndyPR, simeyss, lnester7 and 2 others like this.

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