Role of TLR2 in the Sensing of oxidants and ensuing Inflammation

ISRCTN ISRCTN81682521
DOI https://doi.org/10.1186/ISRCTN81682521
Secondary identifying numbers 5843
Submission date
25/10/2012
Registration date
26/02/2013
Last edited
19/12/2017
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Most cells in your body can detect the presence of something that can cause a disease (a pathogen) like a virus or bacteria, or an environmental factor like pollution. If your cells detect a pollutant like cigarette smoke, they react by removing it from your body in the same way as viruses and bacteria. We believe that susceptibility to infection may be influenced by environmental pollutants like cigarette smoke. We would like to see if this is the case, and if so why this happens.

Who can participate?
Healthy volunteers (smokers and non-smokers).

What does the study involve?
We need blood samples from healthy smokers (within 20 minutes of smoking a cigarette) and non-smokers so that we can look at their response to bacteria and viruses and the effect that smoking has on these responses. These tests will be carried out a laboratory at Imperial College. We would like to take a small sample of your blood - about 10 tablespoons. This will be taken using a needle from a vein in your arm by a trained research nurse or qualified doctor in the Unit of Critical Care Medicine at the Royal Brompton Hospital, and should only take about 20 minutes. You will need to inform us of any medication that you are taking. At the end of the study we will reimburse all your travelling expenses.

What are the possible benefits and risks of participating?
There is a slight risk of a small bruise where the needle is put in, and occasionally people feel faint when blood is taken, but there are no other risks involved. We will only carry out those tests detailed above on your blood sample. We will not carry out any tests for serious infections such as HIV and there is no need to declare such tests on an insurance or mortgage application. In the very unlikely event of your coming to any harm, Imperial College has insurance in place so that you may receive compensation without having to prove negligence on our part. The blood samples you give will be coded before any tests are performed on them, so that you cannot be identified from the samples. All of your details will be kept strictly confidential. Some blood may be stored for future use in research in this area.

Where is the study run from?
Royal Brompton & Harefield NHS Foundation Trust (UK).

When is the study starting and how long is it expected to run for?
August 2008 to August 2013.

Who is funding the study?
Wellcome Trust (UK).

Who is the main contact?
Dr Mark Paul-Clark
m.paul-clark@imperial.ac.uk

Contact information

Dr Mark Paul-Clark
Scientific

Royal Brompton & Harefield NHS Foundation Trust
Sydney Street
London
SW3 6NP
United Kingdom

Email m.paul-clark@imperial.ac.uk

Study information

Study designObservational study
Primary study designObservational
Secondary study designCase-control study
Study setting(s)Hospital
Study typeOther
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleRole of TLR2 in the Sensing of oxidants and ensuing Inflammation: Implications for therapeutic Intervention - an observational study
Study acronymTSI
Study objectivesThe 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
Ethics approval(s)Royal Brompton & Harefield NHS Trust Ethics Committee, 08/H0708/69
Health condition(s) or problem(s) studiedImmunology and inflammation
InterventionBlood will be taken from 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.
Intervention typeOther
Primary outcome measureThe 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 measuresNo secondary outcome measures
Overall study start date06/08/2008
Completion date08/08/2013

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
SexBoth
Target number of participantsPlanned Sample Size: 100
Key inclusion criteriaHealthy volunteer (either a smoker or non-smoker)
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment06/08/2008
Date of final enrolment08/08/2013

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Royal Brompton & Harefield NHS Foundation Trust
London
SW3 6NP
United Kingdom

Sponsor information

Wellcome Trust (UK)
Charity

Queen Square
London
WC1N 3BG
United Kingdom

ROR logo "ROR" https://ror.org/029chgv08

Funders

Funder type

Charity

Wellcome Trust (UK) ref: WT083429MA
Private sector organisation / International organizations
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Editorial Notes

19/12/2017: No publications found in PubMed, verifying study status with principal investigator.