We are delighted to share that Linetty Makawa, Lead Nurse at the NIHR Leeds Clinical Research Facility (CRF), has co-authored a pioneering stroke research paper recently published in the Biomolecules journal.
The study, titled “Rapid Detection of Specific Biomarkers for Differentiation of Stroke Patients from Mimics,” introduces an innovative approach to enhancing the speed and accuracy of stroke diagnosis. Strengthening the partnership between Leeds Teaching Hospitals NHS Trust (LTHT) and the Institute of Cardiovascular and Metabolic Medicine at the University of Leeds (UoL), this research highlights the impact of multidisciplinary collaboration in advancing translational stroke care.
Stroke continues to be one of the leading causes of death and long-term disability worldwide. Early and accurate diagnosis is critical, as treatments are most effective within the first few hours after symptom onset. Yet, distinguishing a true stroke from a “stroke mimic” — a condition with similar symptoms but a different cause — can be difficult, even with advanced imaging and clinical assessments.
In this study, blood samples were analysed from patients with confirmed stroke and from individuals whose symptoms resembled a stroke but were later attributed to other conditions. Researchers identified key blood proteins (biomarkers) associated with brain injury that were present at significantly different levels in stroke patients compared to the mimic group.
The real breakthrough came when researchers combined three of these biomarkers with an existing clinical stroke assessment score. This combination significantly improved the ability to differentiate a genuine stroke from a mimic — paving the way for a rapid, point-of-care blood test that could transform how strokes are diagnosed.
Linetty Makawa, Lead Nurse for the NIHR Leeds CRF, said: “This study brings us closer to using real-time blood tests to support rapid and accurate stroke diagnosis. By integrating key biomarkers with established clinical tools, we can improve the speed and accuracy of assessments and ensure patients receive the right treatment as quickly as possible. Timely diagnosis is crucial—interventions delivered within the first six hours offer the greatest benefit to patients.”
A heartfelt thank you to the lead investigators, Professor Sikha Saha and Professor Kirti Kain (Academic Supervisors, UoL), and to Dr Ahamad Hassan (Clinical Supervisor, LTHT), along with the dedicated team of co-authors: Dr Pragati Kakkar, Dr Meaad Almusined, Dr Tarun Kakkar, and Dr Theresa Munyombwe.
This outstanding achievement not only exemplifies the cutting-edge research taking place here in Leeds but also highlights the leadership, expertise, and innovation within our Clinical Research Delivery. We are incredibly proud of Linetty and the entire team for their contribution to improving stroke diagnosis and care — research that has the potential to make a lasting global impact.
The first participant in Europe to take part in a new breast cancer trial has been recruited in Leeds.
The study supported by the NIHR Research Delivery Network, is testing a new drug called BNT327 (also known as PM8002) to see if it’s safe and works well for people with triple-negative breast cancer (TNBC).
TNBC does not have the three common “receptors” found in most breast cancers, the oestrogen, progesterone, and HER2 receptors. Because of this, it has been more difficult to treat because it doesn’t respond to hormone therapies or drugs that target HER2, making it harder to treat. As a result, TNBC is more likely to come back and spread than other breast cancers and patient outcomes are less good.
BNT327 is a special kind of medicine called a “bi-specific antibody”. That means it’s designed to target two specific proteins in and around cancers including TNBC: PD-L1 and VEGF-A.
PD-L1 helps cancer hide from the immune system, and VEGF-A helps tumours grow by creating new blood vessels; BNT327 works by blocking both proteins. BNT327, given with chemotherapy, aims to helps the immune system find and attack the cancer, slows tumours growth by cutting off its blood supply, treating TNBC.
Professor Chris Twelves, University of Leeds, Consultant Medical Oncologist and Director NIHR Leeds Clinical Research Facility CRF) at Leeds Teaching Hospitals NHS Trust is conducting the study with the CRF team at St James’s University Hospital
Professor Chris Twelves, Director of the NIHR Leeds Clinical Research Facility and Trial Lead said : “There is a particular need for new treatments for people with TNBC so we are especially pleased to be able to offer them this innovative, novel another treatment through this trial” .
The study participant said: “I’m incredibly grateful to the wonderful team running the Leeds trial. Having an additional treatment option has given me renewed hope, and the close monitoring and support of the team have been very reassuring.
Individuals with a specific type of tumour will receive an immunotherapy drug called dostarlimab before surgery, rather than the standard procedure where surgery is carried out first, then sometimes followed up by chemotherapy.
This is the first trial to specifically test the outcomes of this approach in older patients with the disease.
FOxTROT 5, led by the University and supported by the NIHR Leeds Clinical Research Facility, heralds a step towards more personalised, precision oncology in colon cancer patients.
People with the disease, who are at least 70 years old, or have significant additional medical conditions, may be able to take part in the trial, which will be running at 20 hospitals across the UK.
It is hoped that the results will inform standard practice, providing evidence of whether this approach could be safe and effective for these types of patients.
The University of Leeds is the trial sponsor, with its Clinical Trials Research Unit (CTRU) leading the study alongside clinicians. The University’s NHS partner site is St James’s University Hospital – Leeds Teaching Hospitals NHS Trust.
The trial will use dostarlimab to target “deficient mismatch repair” (dMMR) colon cancer – a molecularly distinct colon cancer that has been shown in other trials to respond extremely well to immunotherapy.
Cancer immunotherapies are treatments that use the immune system to find and attack cancer cells. There are several different types and they each use the immune system in a different way and can be administered in various ways.
Addressing health inequality
Professor Jenny Seligmann, Chief Investigator of the FOxTROT programme and Consultant Medical Oncologist at Leeds Teaching Hospitals NHS Trust, said: “This approach has already proved to be good for many younger patients but there’s a lack of evidence for what works for older patients. That’s a significant health inequality, which we hope to address.
“The purpose of FOxTROT 5 is to find an improved treatment for colon cancer patients that have cancer cells with an abnormality called dMMR. Standard chemotherapy treatments can be less successful for these patients.
“We hope this trial will lead to a new treatment for them, as well providing further understanding of the disease for the future.”
Every year, over 44,000 people in the UK are diagnosed with colon cancer and over 16,000 lose their lives because of it.
Patients are usually treated with surgery first and may go on to have chemotherapy afterwards to help prevent the cancer coming back.
However, often old, frail patients aren’t well enough to undergo surgery or necessary anti-cancer treatment afterwards. Delivering an immunotherapy treatment first could prevent that, if this approach is successful.
Most people who develop colon cancer are classed as older or frail, but that group of people isn’t usually eligible for clinical trials, meaning there is little evidence for what works best for them.
FOxTROT 5 is aimed at helping to address that health inequality.
Previous success
The FOxTROT trial platform now has options for most stage 2 and 3 colon cancer patients and has seen great success.
FOxTROT 1, a collaborative study by scientists at Leeds and the University of Birmingham, showed that giving proficient mismatch repair (pMMR) colon cancer patients chemotherapy before, rather than after, surgery reduced the chance of the disease returning within two years by more than a quarter.
The new approach to treating colon cancer has since become a treatment option under NICE (the National Institute for Health and Care Excellence) guidelines. FOxTROT 2 tests whether the approach works in older, frailer pMMR patients.
FOxTROT 3 is investigating whether more intensive chemotherapy can further improve benefits in pMMR patients who can tolerate it. Both are funded by Yorkshire Cancer Research. FOxTROT 4 tests targeted oncology treatment in pMMR colon cancer patients with an abnormality in their tumour called a BRAF mutation. These patients currently have particularly poor outcomes.
The launch of FOxTROT 5 means the trial platform now, in theory, offers a trial for all the older and frail stage 2 and 3 colon cancer patients, although some further checks are required for each patient to ensure the trial is suitable for them.
Dr Stuart Griffiths, Director of Research at Yorkshire Cancer Research, said: “The launch of FOxTROT 5 marks a significant development in the FOxTROT Trial Platform and aligns with the charity’s ambition to bring potential benefits from the research to as many people with bowel cancer as possible, in Yorkshire and across the globe. We are grateful to the charity’s supporters for helping to create an important and unique opportunity for Yorkshire to drive forward this exciting research.”
FOxTROT 5 will be launched at 20 hospitals across the UK in the coming months, with the following already offering the trial to patients:
Ninewells Hospital, Dundee
St James’s University Hospital, Leeds
Churchill Hospital, Oxford
Queen’s Hospital Burton
Queen Elizabeth Hospital Birmingham
University Hospital, Coventry
Ipswich Hospital.
To find out more about how you or a family member could take part in FOxTROT 5, please speak to your hospital doctor.
Ian Johnson has become the first person in the world to join a new part of a brain cancer trial testing a drug designed to boost the effects of radiotherapy.
Ian, aged 50, is taking part in a study testing a new drug called AZD1390, which is being used alongside radiotherapy to treat glioblastoma—a type of brain cancer. The drug is designed to make radiotherapy more effective by stopping cancer cells from repairing themselves after treatment.
Glioblastoma is an aggressive type of brain tumour. The usual treatment involves surgery to remove as much of the tumour as possible, followed by radiotherapy and chemotherapy. However, the cancer often returns. The trial is looking for ways to improve treatment for people who have glioblastoma and cancer spread to the brain from elsewhere in the body.
This newly opened part of the trial is led by Professor Susan Short, a Consultant Clinical Oncologist at Leeds Teaching Hospitals.
Ian, a Senior Crown Prosecutor and father of two, was diagnosed with glioblastoma in December 2023 after experiencing symptoms that led to a scan. He said: “The diagnosis was a huge shock; I’d always been healthy and had no medical issues before this.”
He had surgery to remove the tumour in January, followed by radiotherapy and chemotherapy. Unfortunately, a scan showed the tumour had returned. Because his body didn’t respond well to chemotherapy, Ian’s doctor referred him to Leeds to explore other treatment options. That’s when he learned about this trial using AZD1390.
Ian added: “I felt hopeful when I heard about the study. “It gave me another option, and as someone with a degree in biology, I also wanted to help future patients by being part of research.”
Since starting the treatment, Ian says he’s been able to continue doing the things he loves, like walking, birdwatching, and spending time with his family: “Apart from feeling more tired than usual, I haven’t had any major side effects. The team here has been incredible—supportive, kind, and always there to answer questions.
“I would absolutely encourage anyone who’s given the chance to consider a clinical trial. Every new treatment has to be tested, and I feel proud to be helping in that process. It’s given me hope—not just for myself, but for others in the future.” The trial is being carried out at the NIHR Leeds Clinical Research Facility, a dedicated space for testing new treatments safely and carefully with the support of expert staff. Patients also benefit from the state-of-the-art Bexley Wing at St James’s Hospital, which includes a hotel on the top floor for those travelling long distances.
Professor Susan Short, Clinical Oncologist and Neuro Oncologist at Leeds Teaching Hospitals and the University of Leeds said: “We are really pleased to be offering patients access to promising new treatments like AZD1390 here in Leeds. This part of the trial is an important step in improving care for people with brain cancer.”
Leeds continues to lead the way in cardiovascular research, establishing itself as a premier centre in the UK with over 50 active clinical trials using advanced diagnostic equipment. Thanks to funding from the Leeds Hospitals Charity, the NIHR Leeds Clinical Research Facility at Leeds General Infirmary has acquired a second cardiac ultrasound scanner, commonly known as an ‘echo’ machine.
This additional imaging technology will significantly improve research efforts by allowing more patients to participate in groundbreaking clinical trials. The ultrasound machine has the potential to benefit thousands of patients involved in cardiovascular research at Leeds Teaching Hospitals annually.
Cardiac ultrasound technology is vital in diagnosing, assessing, monitoring, and treating patients across various specialties, particularly in heart disease and cancer research. The high-quality imaging provided by this machine plays a crucial role in developing and adopting new treatment pathways, ultimately improving patient care and outcomes.
Since its installation, nearly 750 scans have been performed, offering invaluable insights into heart health. One patient who has benefited from this advanced technology shared their experience:
“I was diagnosed with a faulty heart valve which required regular echo scans for monitoring. The scans were non-intrusive, quick, and painless. They allowed the medical team to track the condition of my valve and determine the optimal timing for its replacement.”
The expansion of cardiac ultrasound technology at Leeds sets the stage for significant advancements over the next five years. The facility is now positioned to develop into a national hub for echocardiography and clinical cardiac science research.
Julie Corrigan, CRF Inclusion Lead at the Leeds Clinical Research Facility, said:
“The echo machine has enabled us to explore novel echocardiographic imaging biomarkers, which may help detect subtle heart impairments. This can allow us to tailor which cardiac device a patient needs before their pacemaker is fitted.”
She further explained:
“Most recently, we have used the echo machine to determine the presence of heart failure in patients with pacemakers. This has given us unique insights into how heart rate correlates with heart function. The data gathered enables us to individualize medication therapy and optimize pacemaker programming, ultimately improving patients’ quality of life, exercise capacity, and reducing the risk of worsening heart failure.”
This cutting-edge cardiac ultrasound machine marks an exciting step forward in cardiovascular research at Leeds, reaffirming its commitment to pioneering advancements in patient care and treatment innovation.
We are looking for participants for the Nova 301 Trial. This trial will see if an investigational vaccine can protect people 60 years of age or older against symptoms caused by the norovirus stomach bug.
Norovirus is one of the most common stomach bugs in the UK. It can spread easily and most cases are often in care homes and schools. The norovirus stomach bug can cause many unpleasant symptoms like nausea, vomiting, and diarrhoea. Vulnerable people, such as children younger than age 5, adults older than age 60, and people with underlying health conditions, are at greater risk for serious symptoms of norovirus, which may require medical attention.
About the Nova 301 Trial
The Nova 301 Trial will see if an investigational vaccine (a vaccine that is being studied) may be able to prevent symptoms caused by the norovirus stomach bug from developing in people 60 years of age or older. The investigational vaccine in this clinical trial is called mRNA-1403. You cannot catch norovirus by having this investigational vaccine.
Who can join?
This clinical trial is looking for participants. To join, you must:
be 60 years of age or older
be in good health
not currently have a chronic gastrointestinal disease (including irritable bowel syndrome, colitis, oesophageal reflux, or any other medical condition where you have regular vomiting or diarrhoea)
What to expect
Your participation in the Nova 301 Trial will last up to 25 months.
You will attend an initial screening visit, up to 6 additional clinic visits and up to 6 scheduled phone calls with the clinical trial team
You will be given 1 jab, which will be either:
An investigational mRNA-1403 norovirus vaccine; OR
A placebo jab (inactive substance)
You must fill out an electronic diary (eDiary) regularly during your trial participation
Enrolling in this clinical trial is completely your choice. You can leave at any time and do not have to give a reason
Moderna will reimburse participants for their trial-related time and expenses (for example, travel), and the clinical trial team are on hand to support everyone who takes part in the trial.
Contact the clinical trial team today
Contact the research team to find out more about joining the Nova 301 Trial.
Patients who wear facial prostheses after treatment for head and neck cancer have had their portraits painted to illustrate the physical and psychological impact of living with a facial difference.
Fifteen patients, who wear facial prostheses – bespoke removable silicone devices that replace a facial part such as an eye or nose – took part in the Leeds CRF IMPRESSeD study, comparing modern and conventional methods of producing the prostheses in an early look at which technique was preferred by patients and potentially more cost-effective. The study was funded by the National Institute for Health and Care Research (NIHR) and Leeds Hospitals Charity.
The portraits were painted as part of a public engagement project, named “I’m Still Me”, which was inspired by the research and co-created by the patients, researchers, healthcare professionals, artists, and public engagement practitioners. They will be exhibited in the Atrium of the Bexley Wing at St James Hospital, Leeds, from 6 November 2024 to 31 January 2025. The public engagement project was funded by Research England’s Enhancing Research Culture funding stream with additional support provided by a University of Leeds Engagement Fellowship.
The IMPRESSeD study was led by Dr Rachael Jablonski, current NIHR Academic Clinical Lecturer and Specialty Registrar in Restorative Dentistry at the Leeds School of Dentistry and Leeds Dental Institute, as part of her PhD.
Dr Rachael Jablonski
She said: “Head and neck cancer can have a major impact on a patient’s health and wellbeing and receiving a prosthesis can be an important part of the process of coming to terms with the experience.
“I worked with patient and public involvement (PPI) contributors to identify areas for improvement in the processes of making prostheses. Fifteen patients took part in the feasibility trial and were invited to take part in an interview after they had gone through both conventional and new methods. Almost all the patients who took part in the interviews preferred the newer processes of making facial prostheses in our initial study. The next step would be a future full-scale trial.”
The conventional prosthesis manufacturing process involves multiple clinical and laboratory procedures over several hospital visits with highly trained Maxillofacial Prosthetists, who recreate the facial part.
Firstly, an impression of the patient’s face is taken using a silicone or alginate material, which can be claustrophobic or uncomfortable, and may distort the facial tissues, affecting the final product.
Maxillofacial Prosthetists use the impression to pour a plaster model, hand-sculpt a wax pattern, then convert it into a silicone prosthesis. Replacements are needed every two years, but sometimes as often as soon as six months, due to changes in the patient’s face during the healing process; prosthesis wear and tear, and general degradation. Estimates suggest that the process can take up to 10 hours to complete and cost up to £1,500.
New facial prosthesis manufacturing techniques employ 3D facial scanning as a less invasive way of capturing the shape and texture of a patient’s face, as well as computer-aided design using artificial intelligence to reconstruct the facial feature, and 3D printing the design to help produce the facial prosthesis.
Digital technologies have the potential to support or replace steps in the manufacturing processes potentially helping to address pressures on the small numbers of qualified Maxillofacial Prosthetists working in the NHS.
Dr Jablonski worked with patients to identify priority areas for improvement in the manufacturing process, which were getting rid of uncomfortable facial impressions; more closely matching the way their face looked before surgery, and receiving their prosthesis sooner after surgery.
Patients from Leeds Teaching Hospitals NHS Trust and Guy’s and St Thomas’ NHS Foundation Trust in London received facial prostheses made using conventional and digital manufacturing approaches and were asked to assess both methods towards the end of the study.
Dr Jablonski said: “We found that 90% of patients we interviewed preferred digital over conventional processes due to the comfort, speed, hygiene, and perceived positive impact on outcomes associated with digital technology. Some patients felt contactless scanning may offer benefits when a patient’s skin is sore after surgery or radiotherapy, and others considered the computer aided design technology and 3D printing to be sophisticated and a positive step forward.
“However, the patients were also keen to ensure they would not lose out on the skilled finishing touches from the conventional approach.”
I’m Still Me was created as a collaborative arts-science project to share the lived experience of people who wear facial prostheses, bring the research findings out into the wider community, and highlight the valuable role of patients in research and public engagement.
The portraits were created by a group of painters assembled by Salford artist Sarah Morley following her work on a similar, previous project. Together with writers and researchers, the artists worked with the patients to co-design the I’m Still Me exhibition. The portraits are each displayed alongside a narrative describing the patient’s rehabilitation with facial prostheses, to raise awareness of the innovative science, and to raise public awareness about face equality.
Dr Jablonski said: “Research is typically not very accessible to the general public. We knew that when we shared the research, we wanted to make the findings as accessible as possible. There has also traditionally been an underrepresentation of people with visible differences in public life and the media. It was therefore important that the project not only shared our research findings but also communicated key issues that were most important to the patient contributors.
“We hope that I’m Still Me shares messages of face equality and stimulates a reflection on how people should be valued through their own unique stories and contributions.”
Patients’ quotes
Suzie “This is what I am, and this is what I look like.” “Stick with it. Things get better.”
Robin “Cancer has many faces – this is mine.” “Prostheses act as a shield for the public who might be upset if they found out what we really looked like – they provide a level of public acceptability.”
Tim “Wearing my eye patch I get comments, especially from children, like, “Where’s your parrot? “Don’t look back. Look forward and grab life. Whether it’s long or short, grab your life and run with it.”
Rebecca “A prosthetic arm or leg would be functional, but I can’t see out of my prosthetic eye.” “Who is the prosthesis for? Me or the public?”
Peter “We have the results of our cancer surgery visibly on show; it can’t be hidden away.” “All I wanted was a nose the right shape so I could put my glasses on.”
Derek “Being involved in research has been no hardship. I would encourage others to get involved.” “While the processes can take some time, having a prosthesis has been life changing.”
David “I like to get involved with research to try and prevent what happened to me from happening to other people” “I get stressed when people stare at me.”
Chris “It’s my face, what’s it got to do with you?” “I had no option but to wear it. You can’t hide away, and you can’t go around with a big hole in your face, or you’d scare people.”
The NIHR Leeds Clinical Research Facility at Leeds Teaching Hospitals NHS Trust (LTHT) has made a significant stride in the fight against melanoma by recruiting our first patient for an international clinical trial testing a ground-breaking cancer immunotherapy vaccine. LTHT is one of eight sites in the UK exploring a personalised mRNA vaccine designed to prevent recurrence of the most serious form of skin cancer, melanoma.
Matthew Adams, a family man from Apperley Bridge in Bradford, is the first of our patients to be recruited to this trial. An engineering manager for Yorkshire Water, Matt lives with his wife of 36 years, Linda, and their two daughters. Recently, the arrival of his new grandson brought joy into his life, making his health battle even more personal.
In February, Matt was diagnosed with melanoma, and he was admitted to the hospital for treatment in April. “I had the primary “mole” removed, followed by a biopsy of the swollen lymph nodes,” Matt recounts. “I must give special thanks to James Smith, my plastic surgeon, who did an amazing job. He was the first person who fully explained all my options and possible treatments, including the chance of a vaccine trial. His positivity is one of the main reasons I considered it.”
James Smith’s explanation of the vaccine attracted Matt’s interest. However, his oncologist Dr Maria Marples’ support made his decision clear. “Maria is so lovely and kind,” Matt shares. She went through the risks and benefits many times, making me feel comfortable with my choice to take part in the trial.”
After receiving the vaccine, Matt did not experience any physical pain, and he credits the research nurses at LTHT for his care. “The research team at St James’s is amazing,” he says. “They made me feel at ease right from the start. A special mention to Willombe, my research nurse, who has had to put up with me from the start. She has been under a lot of pressure setting up the trial and taking endless amounts of blood.”
Matt encourages other cancer patients to consider participating in clinical trials. “The team at St James’s explains everything from start to finish in a way you can understand,” he emphasises. “Yes, absolutely, I would recommend it.”
The personalised mRNA melanoma vaccine, being developed by Moderna and Merck Sharp and Dohme (MSD), is designed to match the unique genetic signature of each patient’s tumour. The vaccine instructs the body to produce proteins, or antibodies, that target markers found on that patients’ cancer cells. In this trial, the vaccine is combined with the standard-of-care immunotherapy drug, pembrolizumab.
This vaccine technology builds on that used to develop many COVID-19 vaccines and is currently being tested in other clinical trials in a range of cancers. As yet, these vaccines are not approved as safe and effective, so they are not available outside clinical trials. They may, however, represent the next frontier in cancer treatment.
Consultant Oncologist Dr Jane Hook, the Principal Investigator of the trial at LTHT, said. “This clinical trial is using cutting-edge science to personalise cancer treatment and we hope it will increase the chance of cure for people with melanoma. We are excited to be taking part in this important study and grateful to our patients who agreed to participate in the trial.”
UK Lead Investigator Dr Heather Shaw added, “This vaccine has the potential to be a ‘game-changer,’ improving the chance of a cure for people with melanoma and potentially other cancers such as lung, bladder, and kidney tumors.”
The vaccine was administered by Team One Oncology research team. Well done to the team for their efforts.
Melanoma, the most severe form of skin cancer, is marked by the uncontrolled growth of pigment-producing cells. Rising steadily over the past decades, melanoma saw nearly 325,000 new cases diagnosed worldwide in 2020. In the UK, it is the fifth most common type of cancer, with about 8,400 new cases annually.
– A mole that has changed size, shape, or color
– A mole that is painful or itchy
– A mole that is inflamed, bleeding, or crusty
– A new or unusual mark on the skin that persists after a few weeks
– A dark area under a nail not caused by an injury
