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21 March 2013 
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Role of TLR2 in the Sensing of oxidants and ensuing Inflammation
ISRCTN ISRCTN81682521
DOI 10.1186/ISRCTN81682521
ClinicalTrials.gov identifier
EudraCT number
Public title Role of TLR2 in the Sensing of oxidants and ensuing Inflammation
Scientific title Role of TLR2 in the Sensing of oxidants and ensuing Inflammation: Implications for therapeutic Intervention - an observational study
Acronym TSI
Serial number at source 5843
Study hypothesis The aim of this project is to study how oxidants are sensed by Toll like receptors (TLRs)

1. Determine the effects that oxidants have on the ectodomain of TLR2
2. Assess the requirements for the TLR adaptor proteins MyD88 and TIRAP in oxidants dependant signalling
3. To assess the involvement of other PRRs in oxidant induced inflammation
4. Assess the differences in gene activation between classical TLR2 ligands and oxidants
5. Grow out blood-derived stem cells for assessment

More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=5843
Lay summary Lay summary under review 3
Ethics approval Royal Brompton & Harefield NHS Trust Ethics Committee, 08/H0708/69
Study design Observational study
Countries of recruitment United Kingdom
Disease/condition/study domain Immunology and inflammation
Participants - inclusion criteria Healthy volunteer (either a smoker or non-smoker)
Participants - exclusion criteria Does not meet inclusion criteria
Anticipated start date 06/08/2008
Anticipated end date 08/08/2013
Status of trial Ongoing
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants Planned Sample Size: 100
Interventions Blood will be take form volunteers who are either healthy smokers (within 20 mins of smoking a cigarette) or non-smokers. The blood will either be directly plated out into 96 well plates or cells isolated or grown out and characterised for their responses to various agonists and a number of mediators and cytokines will be measured. The total time a volunteer is need for is 20 mins although they may be asked back to participate again.
Primary outcome measure(s) The blood or cellular responses will be compared between smokers and non-smokers. To assess the differences that oxidative exposure will have on smokers just 20 mins after having a cigarette.
Secondary outcome measure(s) No secondary outcome measures
Sources of funding Wellcome Trust (UK) ref: WT083429MA
Trial website
Publications
Contact name Dr  Mark  Paul-Clark
  Address Royal Brompton & Harefield NHS Foundation Trust
Sydney Street
  City/town London
  Zip/Postcode SW3 6NP
  Country United Kingdom
  Email m.paul-clark@imperial.ac.uk
Sponsor Wellcome Trust (UK)
  Address Queen Square
  City/town London
  Zip/Postcode WC1N 3BG
  Country United Kingdom
Date applied 25/10/2012
Last edited 26/02/2013
Date ISRCTN assigned 26/02/2013
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