Blood test to detect cancer returning reaches final trial stage

Researchers at The Christie NHS Foundation Trust and CRUK Manchester Institute, supported by the North West Genomics Laboratory Hub – based at Manchester University NHS Foundation Trust (MFT) – are leading a Cancer Research UK-funded trial investigating a new, potentially game-changing blood test that could detect if melanoma patients are relapsing up to a year before the cancer could be picked up by a scan.

For the first time, patients who have been diagnosed with melanoma at an early stage could be offered a regular blood test for up to five years to determine if their cancer has returned. Patients diagnosed with melanoma at a very early stage typically have it removed through surgery and then monitored through scans.

Approximately 80% of people with early-stage melanoma need no further treatment after surgery. However, for a small percentage of patients, tumours will go on to develop in other places in their body.

The melanoma research team has developed a ground-breaking blood test that can tell doctors whether cancer cells are still present or becoming active, even if a scan looks normal. The test looks for pieces of DNA in the patient’s blood that are known to have been shed from tumours. This is called ‘circulating tumour DNA’, or ctDNA. The data collected from previous work in the laboratory shows that patients who have ctDNA identified in their blood have an extremely high chance of the cancer returning.

Oncologists at The Christie now want to understand if earlier treatment with immunotherapy (a treatment where the body’s own immune system fights the cancer) of patients with ctDNA in their blood, who have a higher risk of relapsing, can improve their survival. The team will compare these patients’ responses with patients whose new tumours are picked up during a routine scan.

If the results of this analysis show patients benefit from earlier intervention, this could pave the way for the NHS to offer a simple blood test to determine which patients need treating early for their melanoma relapse.

Professor Paul Lorigan, Consultant Medical Oncologist at The Christie who is leading on the trial explained: “Not only does this simple blood test tell us if the cancer is returning, but also could give reassurance to patients who don’t have further signs of cancer after surgery that they don’t need further treatment. If our hypothesis is proved to be correct, this will undoubtedly be a step change in how we treat patients in the future. This study focuses on patients with melanoma but potentially the blood test could be used for other cancers in particular lung and kidney as they also respond well to immunotherapy.

Generally, the earlier cancer is discovered and therefore treated, the better the outcome for patients. We just need to prove this theory is right in this instance and how much of an impact it will have on a patient’s chance of survival.

Dr Rebecca Lee, Clinical Lecturer in Medical Oncology at The University of Manchester explained: “We are constantly exploring better ways to treat patients with melanoma. Seeing the first results in the laboratory was a eureka moment for me – this blood test has the potential to be ground-breaking. We have now tested it extensively in the CRUK Manchester Institute laboratory, and it can now be brought to the clinic for the first time to help patients with early-stage melanoma.”

Patients on the DETECTION trial will be monitored by having the blood tests for up to five years after surgery.

The trial, which will involve a total of 1,050 patients from the UK and Australia, has already recruited its first patient at The Christie.

The first patient recruited to the DETECTION clinical trial, Paul Smith (72), a retired geography teacher from Bury in Greater Manchester said: “I discovered a lump growing behind my left ear which came to prominence during lockdown. It was only when I started socialising again that two friends suggested I should get it looked at and I’m glad I did.

“Following initial surgery at Salford Royal Hospital in late July last year, I was referred onto The Christie, where, following further surgery in October, I was told there was no evidence of any further spread of the melanoma but I’d be kept under observation for the next five years which I thought demonstrated a superb level of care. I asked if there were any clinical trials I could participate in as a way of saying thank you and fortunately DETECTION had just opened and was ready to recruit. To be the first patient recruited onto this clinical trial is amazing and I’m delighted to help. I’m aware melanoma is a type of cancer that can easily recur so it’s reassuring that anything could be picked up by the blood test sooner than the scan.”

Michelle Mitchell, Chief Executive of Cancer Research UK said:

Early detection of cancer is a key driver in improving outcomes for people with cancer. The earlier we can detect cancer, the easier it is to treat. If the DETECTION trial shows that a simple test can pick up evidence of cancer before scans, it will make a huge difference for patients.

Prof Caroline Dive, Director of the CRUK Manchester Institute Cancer Biomarker Centre said: “I am excited to see, that after the research to develop our new blood test (a liquid biopsy), the test is now being used in real-time to support our colleagues’ clinical decision making to optimise the care of their patients with melanoma.”

The DETECTION trial is sponsored by The Christie, working in partnership with Cancer Research UK, Peter McCallum Cancer Centre Australia, NIHR and The University of Manchester. The new blood tests are conducted in Dr Dominic Rothwell’s specialist team in the CRUK Manchester Institute’s Cancer Biomarker Centre led by Professor Caroline Dive. Pharmaceutical company Bristol Myers Squibb provided the drug Nivolumab free of charge for the study. Tumour samples will be analysed at the North West Genomic Laboratory Hub (NWGLH), based at MFT’s Saint Mary’s Hospital. 

Dr George Burghel, Principal Clinical Scientist in genomics at the NWGLH, added:

Supporting the DETECTION trial is an amazing opportunity to advance the care of the Melanoma patients and develop cutting edge diagnostic services.