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The University of Southampton
Southampton Clinical Trials Unit

iDx Lung

Title

IDx Lung: Lung Health Checks in Wessex and Yorkshire: Integrated Biomarker Studies

Description

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.

Objectives

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:

  • Health economic analysis of each of the different markers being studied and any combination thereof,
  • Correlation of biomarker results with clinical outcomes and
  • Derivation of optimised algorithms of investigation.

Trial Design

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.

Trial Status

UK - In set up 

Population

Individuals undergoing a Lung Health Check (LHC).

Trial Team:

Project Manager:

Tania West

Trial Manager:

Darran Ball

 

 

 

Essential Trial Documents

 

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