NNUH is first in the world to recruit patient for Phase 2 lung cancer detection research study
The Norfolk and Norwich University Hospitals NHS Foundation Trust (NNUH) has become the first global site to recruit patients to a clinical trial being run by Owlstone Medical (Owlstone).
The study has been designed to support development of a breath test to help identify patients with lung cancer at a much earlier stage to increase the chances of curative therapies. This includes the identification of lung cancer in patients without symptoms and in those who have abnormal findings on radiological imaging such as CT scans.
Phase 2 of the EVOLUTION trial will assess the diagnostic performance of an exogenous volatile organic compound (EVOC®) probe for detection of lung cancer. This probe is metabolized by an enzyme found in the tumour microenvironment around lung cancer cells, producing a unique biomarker of lung cancer on exhaled breath. In addition to acting as a screening tool for the early detection of lung cancer, there is potential for the test to be used to differentiate between benign and malignant lung nodules.
The study has also been designed to allow differentiation between individuals with lung cancer and relevant contrast groups such as patients with Chronic Obstructive Pulmonary Disease (COPD). Phase 1 of the EVOLUTION study successfully achieved key safety and proof of concept milestones.
The first patient to take part in the Phase 2 trial was recruited at NNUH by Professor Eleanor Mishra’s team at the National Institute for Health and Care Research Norfolk Clinical Research Facility based at the Quadram Institute on Norwich Research Park.
Prof Mishra, Respiratory Consultant and Principal Investigator, said: “Lung cancer has the highest death rate for any cancer in the UK. The earlier we catch lung cancer, the more likely we are to be able to cure people. This study has the potential to enable much earlier lung cancer diagnosis, and therefore save many lives.”
Trevor Jackson, 70, from Cringleford, was the first patient to take part in the trial and attended the Quadram Institute Clinical Research Facility on 5 October 2023. He said: “I had pneumonia at Christmas and ended up having a CT scan which showed something on my lung. Luckily, I’ve been given the all clear now, and they asked if I’d be interested in taking part in this research. I was more than happy because you never know, it might help someone else.”
Billy Boyle, co-founder and CEO at Owlstone Medical, the company behind the breath biopsy technology, said: “Results from Phase 1 of the EVOLUTION trial demonstrated the relevance of the molecular pathway targeted by D5-EthGlu and provided crucial evidence to support further test development. With the recruitment of the first patients into Phase 2, we are excited to continue to progress a test that has the potential to transform lung cancer diagnosis by substantially increasing the uptake of testing, leading to more cases of lung cancer being caught early and significantly reducing mortality and costs. Our nodule management test also holds the potential for more effective identification of benign nodules, reducing unnecessary biopsies and surgery.”
In total up to 350 people will take part in the study across three sites in Europe and six sites in the UK. Sites in the UK, including Norfolk and Norwich University Hospital and Royal Papworth Hospital, Cambridge, are supported in delivering this study by NIHR the nation’s largest funder of health and care research.
Notes to editors
Breath Biopsy represents an entirely new way to determine the chemical makeup of breath by measuring volatile organic compounds (VOCs), gaseous molecules that can be sampled quickly and non-invasively. VOCs originate from all parts of the body as the end product of metabolic processes, making Breath Biopsy applicable to a wide range of diseases including lung cancer, liver disease, and digestive disease. Breath also contains microscopic aerosol particles from the lungs and airways, which can contain a wide range of biomarkers including for infectious disease. The nature of Breath Biopsy therefore makes it perfectly suited to addressing two of the major challenges of healthcare today: early detection of disease and precision medicine.
Exogenous VOC (EVOC) Probes are a reliable and highly sensitive alternative to the detection of endogenous biomarkers, as is standard in liquid biopsy, which are often found at very low levels and so are difficult to detect in early disease. EVOC Probes instead are engineered to release a volatile reporter on breath after cleavage by a specific target pathway. This approach offers the advantage that compounds not normally found at significant levels in breath can be introduced into the body (individually or as a cocktail) to explore how they are absorbed, metabolized or excreted. Further, high levels can be administered, substantially improving signal-to-noise ratios compared to signals from endogenous sources and thus greatly improving reliability of detection.
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