Biomarkers in Lung Health Checks (ALPINE)
Research type
Research Study
Full title
Assessment of Novel Biomarkers in participants Undergoing Targeted Lung Health Checks
IRAS ID
318429
Contact name
Sam Janes
Contact email
Sponsor organisation
UCLH/UCL Joint Research Office (part of the Research Directorate)
Clinicaltrials.gov Identifier
Z6364106/2023/02/99, UCL data protection number
Duration of Study in the UK
4 years, 9 months, 20 days
Research summary
Low-dose CT (LDCT) screening for lung cancer (LCS) has been shown to reduce lung cancer specific mortality in multiple randomised controlled trials. However, although LDCT screening has been demonstrated to reduce cancer-specific mortality, there remain outstanding questions regarding how screening can be implemented. In particular, indeterminate nodules are common, and can be challenging to distinguish from benign nodules on CT appearances alone. Furthermore, distinguishing cancers which are likely to become clinically significant from those that will remain indolent is challenging, but essential to prevent over-treatment and overdiagnosis. There is significant interest in using a multi-modal approach to LCS, incorporating biomarkers obtained from minimally-invasive samples alongside LDCT to improve ability to recognise clinically-significant lung cancers at an early stage.
The Targeted Lung Health Check (TLHC) programme is an NHS programme with the aim of using LDCT screening in appropriately high-risk individuals to improve early diagnosis and survival in lung cancer. The North Central London TLHC programme is due to start in mid-2022.
The purpose of the ALPINE study is to develop a platform to allow collection of minimally-invasive samples (potentially including but not limited to peripheral blood, buccal swabs, stool samples and exhaled breath condensate) from participants undergoing screening within the North Central London TLHC programme. The use of such biomarkers in the diagnosis of lung cancer is a rapidly developing field and novel techniques and technologies are continuously under development. The ALPINE study will generate a cohort with matched biosamples, CT scans and clinical data which will be uniquely well placed to serve to develop or validate biomarkers in lung cancer screening and risk prediction.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
23/EM/0114
Date of REC Opinion
15 May 2023
REC opinion
Further Information Favourable Opinion