Condition category
Not Applicable
Date applied
25/10/2012
Date assigned
26/02/2013
Last edited
09/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mark Paul-Clark

ORCID ID

Contact details

Royal Brompton & Harefield NHS Foundation Trust
Sydney Street
London
SW3 6NP
United Kingdom
-
m.paul-clark@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

5843

Study information

Scientific title

Role of TLR2 in the Sensing of oxidants and ensuing Inflammation: Implications for therapeutic Intervention - an observational study

Acronym

TSI

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

Ethics approval

Royal Brompton & Harefield NHS Trust Ethics Committee, 08/H0708/69

Study design

Observational study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Immunology and inflammation

Intervention

Blood 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 type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

No secondary outcome measures

Overall trial start date

06/08/2008

Overall trial end date

08/08/2013

Reason abandoned

Eligibility

Participant inclusion criteria

Healthy volunteer (either a smoker or non-smoker)

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 100

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

06/08/2008

Recruitment end date

08/08/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Wellcome Trust (UK)

Sponsor details

Queen Square
London
WC1N 3BG
United Kingdom

Sponsor type

Charity

Website

Funders

Funder type

Charity

Funder name

Wellcome Trust (UK) ref: WT083429MA

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes