CAMBRIDGE, U.K.—Early diagnosis and intervention is the best way to increase chances for a positive outcome for any disease, and that is especially true for cancer. While liquid biopsy options allow for fairly early diagnosis by detecting the DNA that tumors shed into the bloodstream, some companies, such as Owlstone Medical, are hoping to enable diagnosis even earlier in the course of cancer. In pursuit of that goal, Owlstone Medical has teamed with up Cancer Research UK to launch the PAN Cancer trial for Early Detection of Cancer in Breath.
The trial is being conducted in collaboration with researchers at the Cancer Research UK Cambridge Centre, the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust. Prof. Rebecca Fitzgerald, who is co-lead of the Cancer Research UK Cambridge Centre Early Detection Programme, is chief investigator for the trial. Fitzgerald is also Professor of Cancer Prevention at the MRC Cancer Unit, and an Honorary Consultant in Gastroenterology and General Medicine at Addenbrooke’s Hospital, Cambridge.
The trial will recruit 1,500 patients through Addenbrooke’s Hospital. Initially, the trial will consist of patients who are suspected to have esophageal or stomach cancers, and eventually it will expand to include prostate, kidney, bladder, liver and pancreatic cancers as well.
Owlstone Medical is working on the development of a breathalyzer for early disease detection, and hopes to enable “breath biopsies” for early, non-invasive cancer diagnosis. The Breath Biopsy platform is based on the analysis of volatile organic compounds (VOCs), gaseous molecules found in the breath. The platform will be the focus of the PAN Cancer trial, with breath samples collected with Owlstone’s ReCIVA Breath Sampler and processed in the company’s Cambridge laboratory.
“There is increasing potential for breath-based tests to aid diagnosis, sitting alongside blood and urine tests in an effort to help doctors detect and treat disease,” said Billy Boyle, co-founder and CEO at Owlstone Medical. “The concept of providing a whole-body snapshot in a completely non-invasive way is very powerful, and could reduce harm by sparing patients from more invasive tests that they don’t need.
“Our technology has proven to be extremely effective at detecting VOCs in the breath, and we are proud to be working with Cancer Research UK as we look to apply it towards the incredibly important area of detecting early-stage disease in a range of cancers in patients.”
“Every minute, all of the blood in your body passes through your lungs,” Chris Claxton, head of Investor Relations at Owlstone Medical, tells DDNews, “so by taking a breath sample for a minute, you’ve effectively sampled the entirety of the body.”
“It’s well known that cancer has an altered metabolism, which means that some of the ketones and alkenes and alkanes and other carbohydrates that are related to metabolism will find themselves in higher quantities in the blood,” he explains. “And any volatile chemicals in the blood get into your breath, and we can capture that. That’s the whole premise behind our early-stage cancer trial: that the altered metabolism which happens first in cancer, even before the cells start breaking down and releasing circulating tumor DNA in the blood so that liquid biopsy can potentially detect it, results in changes in the levels of certain metabolites that are detectable on breath. So what we're doing right now with the PAN trial is trying to prove this, and identify which specific biomarkers relate to cancer and identify that specific cancer.”
The LuCID trial is seeking to evaluate Owlstone’s Breath Biopsy platform in lung cancer. According to Claxton, it is the largest breath-based trial ever, enrolling more than 4,000 patients from 26 countries across Europe, with preliminary results possible either later this year or in early 2020.
“We urgently need to develop new tools, like this breath test, which could help to detect and diagnose cancer earlier, giving patients the best chance of surviving their disease,” said Fitzgerald. “Through this clinical trial, we hope to find signatures in breath needed to detect cancers earlier—it’s the crucial next step in developing this technology. Owlstone Medical’s Breath Biopsy technology is the first to test across multiple cancer types, potentially paving the way for a universal breath test.”
“Screening technology is an acute need,” Claxton agrees. “And practically speaking, in terms of what you can do when you discover disease, the most effective treatment for virtually any cancer is surgery. But in order for surgery to be effective, you have to catch it really quite early, before it starts to spread through the tissue—or even worse, go metastatic.”
Nearly half of all cancers are diagnosed at a late stage in the U.K., according to a 2016 publication (http://www.ncin.org.uk/publications/survival_by_stage). Cancer Research UK has named early cancer detection as one of its top priorities, and intends to invest more than £20 million into such research annually by 2019.
The PAN Cancer trial is slated to run through 2021, though Claxton notes that should the trial uncover any promising biomarkers, there will be a follow-on trial to validate their diagnostic potential.