Multiplex blood and tissue biomarkers for early lung cancer detection in a population undergoing computed tomographic (CT) screening: the iDx-Lung study


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Michelle Chesters1, Peter Johnson1, Victoria Goss1, Jocelyn Walters1, Darran Ball1, Claire Eckert2, Sam Wilding1, Jacqueline Nuttall1, Kathy Potter1, Debora Joseph-Pietras1, Kate Rolfvondenbaumen1, Catherine Pointer1, Hang Phan1, Bethany Shinkins2, Philip Crosbie3, Kevin Franks4, Isabel Macdonald5, Graham Healey5, Helen Oxford6, Paul Smith4, Ravinder Pabial7, Duncan Whitney8, Matthew Callister4, Richard Neal2, Gareth Griffiths1
1University of Southampton, 2University of Leeds, 3University of Manchester, 4Other, 5Oncimmune, 6Inivata, 7Roche, 8Johnson & Johnson

Abstract

Background

Circulating tumour DNA in plasma, autoantibodies to oncoproteins or tumour-related peptides in serum, and transcriptome changes in respiratory epithelium are all under investigation as means of improving lung cancer detection. Large scale pilot studies offering CT screening to people at high-risk of lung cancer are also underway. The iDx-Lung study will evaluate a range of potential early diagnostic markers of lung cancer in this population, to determine whether they can increase the efficiency of screening, either singly or in combination.

Method

Co-ordinated by the NCRI Southampton CTU, blood and nasal brushing samples will be collected from 10,000 consenting participants invited for a screening CT scan in Southampton and Leeds. Serum samples will be analysed for tumour markers (Roche, 6TM) and autoantibodies (Oncimmune EarlyCDT Lung test).  In participants with positive or intermediate CT findings, plasma will be analysed for circulating tumour DNA (Inivata InVisionFirst ® assay), and nasal brushing samples will undergo whole transcriptome analysis by RNAseq (J&J). Clinical and analytical data will be integrated in a central data repository (BC Platforms). The primary endpoint of the study is lung cancer diagnosis by 3-year follow-up.  Assuming a prevalence of 3%, 3,850 participants in each site will be sufficient to independently validate a prediction model with 45 parameters.

Results

The study opened to recruitment in May 2021.  Complex planning to ensure samples are collected, processed, stored and sent to analytical laboratories has been finalised. This includes a large collaborative effort to create an effective process to ensure up to date results are available to the lung cancer clinical team each week. The partners have also worked together to build the data repository service which includes a study monitoring ’dashboard’ to enable tracking of recruitment rate and other milestones.

Conclusion

The iDx-Lung academic and industrial partners have successfully completed the set-up phase of this large-scale translational study and patient recruitment and sample collection is underway.

Impact statement

Biomarkers will be evaluated as markers for early detection of lung cancer to improve current screening programs.