IDx Lung : Lung Health Checks in Wessex and Yorkshire: Integrated Biomarker Studies
Low dose CT (LDCT) scanning is the modality of screening for lung cancer in at risk populations. Low dose CT screening has been trialled in the United States (NLST) and Europe (UK Lung Cancer Screening Trial and NELSON) demonstrating reduction in mortality from lung cancer by 19-20%. CT screening is labour intensive with significant cost implications. It is possible that a multi-modality approach which includes blood biomarkers and other surrogate tissue in addition to CT scanning is required to optimise screening for lung cancer and improve early diagnosis and survival.
There are various promising biological tools that might be tested for utility alongside this large national pilot programme for Lung Health Checks and low dose CT scans. These include autoantibodies, circulating tumour DNA, serum based tumour markers and nasal epithelial transcriptomics.
The primary purpose of the present study is to determine whether adding blood or tissue biomarkers to low-dose CT scanning improves diagnostic performance in risk-stratified population screening for lung cancer, in comparison with currently-used risk prediction methods.
Secondary objectives include:
This is a prospective cohort study for the collection of blood for autoantibody, protein and nucleic acid biomarkers, and nasal epithelium for transcriptomic analysis from individuals attending for lung health checks at mobile scanners in Wessex and Yorkshire. During the period of the study, individuals undergoing a Lung Health Check will be approached by a member of the clinical team or an appropriately trained member of the research team and asked if they are willing to participate in this study. Consent will be taken and samples obtained in mobile units in convenient community locations, co-located with the clinical evaluation and scanning units of the LHC. No additional clinical data will be collected in the iDx lung biomarker sub-study but biological samples will instead be linked to data collected as part of the main study.
Closed to recruitment. In follow-up.
Individuals undergoing a Lung Health Check (LHC).
This trial is funded by UK Research and Innovation, with funding support from Cancer Research UK.
Find out more about iDx Lung on the Cancer Research UK website .
Victoria Goss
Jocelyn Walters
Angelica Cazaly
Charlie Roberts
Email: idxlung@soton.ac.uk
iDx Lung - Protocol v6 06-Feb-2023
iDx Lung - Master Patient List Soton v1 28-Apr-2021
iDx Lung - Site Delegation Log Soton v1 28-Apr-2021
iDx Lung - Screening Log v3 27-Jan-2022
iDx Lung - GP Letter v1 08-Feb -2021
iDx Lung - Laboratory Manual v7 18-Jan-2023
iDx Lung - Quick Ref Guide Sample Collection v2 02-Nov-2021
iDx Lung - Sample Transfer Form v1
iDx Lung – Topic Guide Qualitative Study v1 25-Nov-2021
iDx Lung – Short PIS v2 15-Nov-2021
iDx Lung – PIS Patients Qualitative Study v1 24-Nov-2021
iDx Lung – PIS Clinicians Qualitative Study v2 27-Jan-2023
iDx Lung – Consent Patients Qualitative Study v1 24-Nov-2021
iDx Lung – Consent Clinicians Qualitative Study v2 27-Jan-2023
Multiplex blood and tissue biomarkers for early lung cancer detection in a population undergoing computed tomographic (CT) screening: the iDx-Lung study. Peter Johnson, Michelle Chesters, et al.
Abstract presentation at 3 conferences in late 2021; the CRUK Early Diagnosis Conference, the NCRI conference and the University of Southampton Cancer Sciences conference.
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