Revolutionary blood test could transform early diagnosis of lung cancer, study finds

A blood test developed as part of pioneering research at The University of Nottingham is offering new hope for increasing survival rates from deadly lung cancer by significantly enhancing the early detection of the disease, a study has shown.

The NHS Early detection of Cancer of the Lung Scotland (ECLS) study has revealed that taking the EarlyCDT-Lung® blood test resulted in a 36% reduction in late stage lung cancer compared to standard clinical practice – a statistically significant reduction compared to the current NHS standard of care.

The results have been published in the European Respiratory Journal in an online pre-print of the peer-reviewed results.

Pioneering investigators

The EarlyCDT-Lung blood test is based on pioneering research into the body’s immune response to cancer carried out over the last 25 years by Professor John Robertson, Professor of Surgery and Director of the Centre of Excellence for Autoimmunity in Cancer (CEAC) at the University of Nottingham and further developed when he was Chief Scientific Officer (2003-2013) of Oncimmune Ltd, a spinout company of the University of Nottingham.

Professor Robertson with others helped design the ECLS study along with the PI and lead author of the ERJ paper Professor Frank Sullivan, St Andrews University. Robertson was a co-investigator on the study alongside other colleagues at the University, including immunologist Emeritus Professor Herb Sewell, Nottingham’s former Pro-Vice-Chancellor for Research, and Professors Denise Kendrick and Kavita Vedhara in the Division of Primary Care, who led the evaluation of psychological and behavioural outcomes which have been published in other peer-reviewed journals

The EarlyCDT-Lung blood test, which is commercially available through Oncimmune, is the result of more than two decades of research from a creative idea through laboratory research, product development and randomised clinical trial.

He added: “It was very satisfying to see it being supported in the NICE review earlier this year and to follow its increasing use in many countries across the world for the early detection of lung cancer.”

Longer follow-up in the ECLS study is ongoing and, based on these earlier stage results, it is expected that a significant reduction in lung cancer deaths will also be shown in a subsequent publication.

Non-invasive detection

The ECLS study involved 12,215 individuals who were either smokers or ex-smokers and at high risk of developing lung cancer. Participants were randomised either to receive a new intervention or to receive the current standard of care. For those receiving the EarlyCDT-Lung® test, researchers were able to check if the individual’s immune system had produced antibodies against cancer antigens (protein) which could be detected in their blood. If the test was positive the participants were scheduled to have CT scans of the chest every six months for two years unless a lung cancer was diagnosed within the two-year period.

ECLS is the first trial conducted worldwide as a phase IV evaluation of a blood-based biomarker antibody panel for early detection of lung cancer. Body (CT) scanning has been the preferred method of detection of early stage lung cancer but this requires large imaging infrastructure, is costly and CT scans involve radiation exposure. The safety of screening patients with CT scans over many years, for example more than three years, with cumulative radiation exposure has not been assessed.

A blood test like EarlyCDT-Lung could be repeated frequently and CTs only start when there is a positive blood test. EarlyCDT-Lung is a new and exciting development and further improvements in the approach of an initial blood test for lung cancer and for other types of cancer are expected with future research and development. The University of Nottingham’s CEAC is continuing research in this important area of early cancer detection.

Largest lung cancer detection trial

When the trial began, the significance of the research was heralded by Scotland’s Chief Medical Officer, Sir Harry Burns, who said: “The earlier a cancer is diagnosed the greater the chance it can be treated successfully, and currently 85 per cent of patients with lung cancer remain undiagnosed until the disease has reached an advanced stage.”

The study was first presented in the president’s Session of the World Lung Cancer Congress in Barcelona in September 2019 and in March this year, the National Institute for Clinical Excellence (NICE) in the UK issued advice across NHS England confirming that a review of EarlyCDT Lung showed it was a reliable diagnostic tool for determining cancer risk in patients with lesions on their lungs known as Indeterminate Pulmonary Nodules (IPNs).

The ECLS trial is believed to be the largest randomised controlled trial for the detection of lung cancer using blood-based biomarkers. The trial is supported by the University of Dundee, NHS Tayside and co-funded by Oncimmune, the Scottish Chief Scientist Office and the Scottish Government. It involves collaborators at the University of Glasgow, with further work from the Universities of Aberdeen, St Andrews, Nottingham and Toronto, NHS Scotland, Scottish Government, The Canberra Hospital and Oncimmune. Tayside Clinical Trials Unit was responsible for trial delivery, data management and analysis.

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