P4-Lung Health Check (P4-LHC) Pilot Study

• Research type

  Research Study

• Full title

  Feasibility of Home Urine Collection for Lung Health Check (P4-LHC)

• IRAS ID

  344969

• Contact name

  John Field

• Contact email

  j.k.field@liverpool.ac.uk

• Sponsor organisation

  University of Liverpool

• Duration of Study in the UK

  0 years, 11 months, 30 days

• Research summary

  Early detection of lung cancer (e.g. using low-dose CT screening, as in the NHS Targeted Lung Health Check - TLHC) saves lives. However, this is currently only used for those considered high risk based on questionnaire-based risk scores dominated by age and smoking. Also, the thought of having to have a scan can be off-putting.
  An independent measure of cancer risk be provided by molecules (GAGs) found in urine; these can be provided as home use kits (where people send a urine sample by post) and may also identify high risk people who have not smoked as much (currently not offered a low-dose CT scan).
  P4-LHC is a feasibility study to determine if those who are currently invited for the NHS TLHC (age 55 to 74 with any history of smoking) will provide home urine samples, whether or not they have responded to their TLHC invite and if (if they responded) whether they are either high or low risk by current risk scores. Those who have not, so far, accepted their TLHC invite will be encouraged to do so and it is hoped that this novel approach for home sample collection will inspire them to engage.

  The invites will be sent by Liverpool University Biobank, who will also receive the urine samples. Part of each sample will be sent to a Swedish company (Elypta AB) who will measure the new GAG biomarkers. Subjects will not get their results (as the tests have not been fully validated yet) and they will not be used to change treatment (subjects will continue with their usual care).
  The data generated by this feasibility study will be used to design a larger studies, of a suitable size to determine if the GAG biomarkers will aid early cancer detection, improve on current cancer risks scores and ultimately help save lives.
  

• REC name

  North West - Greater Manchester East Research Ethics Committee

• REC reference

  24/NW/0283

• Date of REC Opinion

  7 Nov 2024

• REC opinion

  Further Information Favourable Opinion