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ISRCTN
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ISRCTN28270972
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ClinicalTrials.gov identifier
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Public title
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Disease biomarkers in amyotrophic lateral sclerosis/motor neuron disease
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Scientific title
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Acronym
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ALS Biomarkers Study
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Serial number at source
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6160
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Study hypothesis
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This study will evaluate the expression of neurofilaments and of other relevant molecules in blood samples taken from individuals with amyotrophic lateral sclerosis at different time points during the development of the disease. Our aim is to validate easily accessible disease biomarkers functioning as reliable predictors of disease severity and capable of providing information about the stratification of the disease phenotypes. Control groups will include healthy individuals and patients with a compressive radiculopathy. Recruitment will take place in 4 motor neuron disease Clinics serving a population of approximately 7,000,000 in North-East London, Heredforshire and Essex. A similar study is currently ongoing in animal models of the disease.
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Lay summary
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Ethics approval
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MREC approved (ref: 09/H0703/27)
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Study design
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Multicentre non-randomised interventional diagnosis trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Topic: Dementias and Neurodegenerative Diseases Research Network; Subtopic: Motor neurone disease; Disease: Motor neurone disease
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Participants - inclusion criteria
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1. Diagnosis of definite or probable amyotrophic lateral sclerosis (ALS) according to the El Escorial Criteria
2. Greater than 16 years of age, either sex
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Participants - exclusion criteria
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ALS/motor neuron disease (MND) patients unable to consent
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Anticipated start date
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24/06/2009
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Anticipated end date
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01/02/2011
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Planned sample size: 100; UK sample size: 100
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Interventions
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1. Blood tests
2. Venepuncture
Study entry: registration only
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Primary outcome measure(s)
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The rate of neurological decline as measured by the ALS Functional Rating Scale Revised (ALSFR)
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Motor Neurone Disease Association (UK) (ref: Mal.../Apr08/RF/6039)
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Trial website
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Publications
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Contact name
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Dr
Ching-Hua
Lu
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Address
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Institute of Neurology Queen Square London , Queen Square
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City/town
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London
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Zip/Postcode
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WC1N 3BG
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Country
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United Kingdom
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Email
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chinghua.lu@gmail.com
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Sponsor
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Barts and The London NHS Trust (UK)
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Address
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9 Prescot Street
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City/town
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London
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Zip/Postcode
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E1 8PR
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Country
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United Kingdom
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Sponsor website:
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http://www.bartsandthelondon.nhs.uk/
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Date applied
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11/08/2010
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Last edited
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11/08/2010
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Date ISRCTN assigned
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11/08/2010
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