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New trial to test novel diagnostic for bladder cancer recurrence

Written by Louise Stanley on . Posted in Clinical trials, Early diagnosis and detection.

Nonacus, an early cancer testing company, has announced two West Midlands-based trials to assess a new way of monitoring for recurrence of bladder cancer, using a novel test developed in collaboration with researchers from BHP founding-member the University of Birmingham.

The at-home urine test uses Nonacus’ highly-sensitive liquid biopsy technology, which was developed in conjunction with a panel of biomarkers developed by researchers from the University’s Bladder Cancer Research Centre.

Called Galeas Bladder, the test was developed while the company based itself at the University’s bio-incubator, the BioHub Birmingham, and a previous Cancer Research UK-funded study has already shown that it can accurately and consistently detect the presence of bladder cancer from a urine sample.

Professor Rik Bryan, Director of the Bladder Cancer Research Centre, said: “These trials are the culmination of eight years of collaborative research and development between the University of Birmingham and Nonacus, which has the potential to help the millions of patients at higher risk of bladder cancer across our country and worldwide.”

Tony Hickson, Chief Business Officer at Cancer Research UK said: “As funders of much of the world-class, cutting-edge cancer research happening in the UK, we offer unique opportunities to commercial partners looking for early involvement in new discoveries. Having Nonacus on board to help transform promising findings in the lab into a new non-invasive test to diagnosis bladder cancer is a testament to how commercial collaborations have the potential to transform the lives of patients. We are looking forward to seeing the next steps as the test is developed and rolled out to the UK and beyond.”

Jeannie Rigby, CEO of Action Bladder Cancer, said ” Bladder cancer can often be diagnosed late and has a high level of recurrence – which can lead to poor outcomes for patients – and bladder cancer has been neglected in terms of new research in the past. Action Bladder Cancer UK, bladder cancer patients and their families, welcome this exciting development in improving testing for bladder cancer.”

Richard Parker, Mayor of the West Midlands, commented: “Health-tech is about better care for patients, shorter waiting times and more good jobs here in the West Midlands. Through my Growth Plan we are making this one of the best places in the country to develop and roll out new treatments – from expanding our innovation clusters to supporting local medtech businesses to grow and export. The technology I’ve seen today is proof that when we back science, patients and the economy both win.”

Peter Kyle, Secretary of State for Science, Innovation and Technology, added: “In a region renowned for engineering, with Richard Parker as Mayor, the West Midlands is setting the pace for medical technology. Nonacus’ innovative approach to testing for bladder cancer will help save patients time and the NHS money. Life sciences is a growth sector for the West Midlands and the UK as a whole combining the power of our universities, the creativity of our businesses and the strength of our NHS.”

Strict regulations needed to address commercial health self-test concerns

Written by Louise Stanley on . Posted in Early diagnosis and detection.

Far greater regulation is needed for off-the-shelf health tests, due to considerable concerns over both suitability of the tests for the public, and accuracy of claims made on-package.

In a series of papers published by The BMJ, researchers from BHP founder-member the University of Birmingham funded by the NIHR Birmingham Biomedical Research Centre reviewed a range of commercially-available health tests bought in shops. The work was carried out due to concerns that directions for use, usability of equipment, and incorrect interpretation of results could cause harm.

Thirty self-test kits were purchased from major supermarkets, pharmacies and health and wellbeing shops, including tests for vitamin deficiency, blood cholesterol, menopause and bowel cancer. Accuracy claims were made for 24 of the tests, and most (14/24; 58%) claimed a performance of at least 98% accuracy, sensitivity or specificity. However, evidence supporting these accuracy claims was largely unavailable or didn’t provide sufficient information for the likely end users of such tests.

Where information about the methods used to estimate test accuracy was available in instruction leaflets (17/30 tests), the accuracy of five tests (5/17; 29%) was evaluated against a similar test rather than a more reliable and accurate test. In addition, the descriptions of participants involved in these studies was mostly lacking, preventing an assessment of the relevance of accuracy estimates to the general public.

The study also highlights issues with the usability and safety of tests, with 18 self-tests being identified as having potential to give an erroneous result or action. The team also identified:

  • 11 tests with problems in the equipment
  • 10 with problems in the sampling process
  • 15 with problems in the instructions or the interpretation of the results

Researchers involved in the study are now calling for better regulation and guidance for manufacturers, retailers and healthcare professionals to protect consumers of off-the-shelf health self-tests.

Professor Jon Deeks at the University of Birmingham and corresponding author of the study said: “A plethora of new health self-tests have emerged in recent years and are available to buy from many high street supermarkets and pharmacies in the UK. While these kits have been approved for sale, they are not subject to the same stringent regulations as pharmaceutical products.

“Our recent research raises concerns about the suitability, accuracy and usability of many of the self-testing products available that require users to sample, test and interpret results themselves. In some cases, it is unclear how accuracy claims are supported, and there is no requirement of manufacturers to share the evidence behind these claims.

“Our findings highlight concerns about the value of these self-tests because the instructions for use for many of them recommended seeing a doctor regardless of the test result (positive or negative).”

Dr Clare Davenport, Clinical Associate Professor at the University of Birmingham and co-author of the study said: “The wide range of off-the-shelf tests now available to the public are not endorsed by the NHS and evidence for their benefit is lacking. This is in contrast to well-established self-tests, such as pregnancy tests.

“We are worried that consumers concerned about their health and tempted by the convenience of buying a test over the counter may be harmed if they use these tests in the wrong way.”

New medicines or interventions must undergo a stringent regulatory process, including clinical trials and registration with the MHRA. In contrast, medical self-test devices are subject to less stringent checks by Notified Bodies, and this has allowed certain self-tests to be sold in the UK, despite them raising concerns.

New regulatory standards should ensure better reporting of studies of self-tests to support transparency of test claims, according to the research team. The researchers also assert that more emphasis should be placed on ensuring the clinical studies of self-tests are conducted appropriately. In particular, self-tests should not only be tested in laboratories, but they should also be evaluated by the people and for the purposes for which they are intended to be used.

Dr Clare Davenport said: “The same consideration given to pharmaceuticals should be given to self-testing where some, such as pregnancy tests, could be sold over the counter and others that carry greater risk of misuse are sold only with the support of a pharmacist. These latest studies have also shown that information and data that support claims of accuracy, specificity or sensitivity needs to be available to the public.”

Professor Jon Deeks said: “Current regulations for the use of self-testing kits in a commercial setting are not adequately protecting consumers. Several of the self-test manufacturers refused to provide us with reports of their studies, which support their claims, stating that they were “commercially confidential”. Legally, they do not need to share this information. However, for all matters of our health, it really is important that the evidence upon which health decisions are made is available and can be scrutinised.”

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Birmingham teenager first in UK to receive groundbreaking diabetes treatment

Written by Louise Stanley on . Posted in Birmingham Health Partners, Early diagnosis and detection, Inflammation and chronic disease.

A young patient identified by the ELSA study as having early stages of Type 1 Diabetes, has received treatment to delay the condition.

Sam, aged 14 and from Kings Norton, was the first to receive the new drug, Teplizumab, at the Clinical Research Facility at Birmingham Children’s Hospital.

Sam’s dad, Chris, has Type 1 diabetes and knowing that family members are more likely to develop the disease, Sam was screened for early stages of the condition and learnt he would develop Type 1 Diabetes. However, there was good news for the family when Sam was offered Teplizumab, a new treatment to delay the onset of the chronic illness. Past trials have proven that Teplizumab delays insulin-dependent diabetes for up to three years.

Sam’s mum, Louise, explained: “I know from Sam’s dad just how stressful life with Type 1 Diabetes is, having to constantly monitor your blood sugar and carry insulin with you at all times. We’re so happy that Sam doesn’t have to worry about his blood sugar yet, especially while he is doing his GCSEs. He can just be a normal teenager.”

Teplizumab is prescribed on a case-by-case basis for children who have been recently diagnosed with type 1 diabetes and are at early stages.

Dr Renuka Dias, a researcher from University of Birmingham’s Department of Applied Health Sciences and Consultant Paediatric Endocrinologist working at Birmingham Women’s and Children’s Hospital, said: “Being able to delay insulin-dependent diabetes will have a huge impact on a child’s life. It means we are letting children have a normal childhood for much longer.”

Dr Dias and her specialist team at the Clinical Research Centre who were involved in Sam’s care have also been integral to a first-of-its-kind study, led by the University of Birmingham, to screen children aged 3 to 13 to find out their risk of developing type 1 diabetes. The study aims to allow treatment to begin sooner and, as in Sam’s case, delay the start of the condition.

The ELSA study has screened over 20,000 children in the UK for Type 1 Diabetes in the last two years. The study is now scaling up throughout Europe.

Unfortunately, it often takes a child becoming seriously unwell for a diagnosis of Type1 Diabetes to be made. Through the study, families identified with a child who is at-risk can begin educating themselves about the condition and learning about the options for management before they find themselves in that crisis situation.

Support and education has been made available to study participants. In addition, some children, like Sam, will be eligible to explore treatment options that could delay the onset of the condition.

Parth Narendran, Professor of Diabetes Medicine at the University of Birmingham and lead for the Type 1 Diabetes clinical service at the Queen Elizabeth Hospital Birmingham (QEHB), said: “We hope that the ELSA study will lead to the roll-out of Type 1 Diabetes early detection programme for children in the UK and that many more children could then benefit from potential treatments to delay Type 1 Diabetes in future.”

Birmingham Women’s and Children’s Hospitals, the University of Birmingham, and University Hospitals Birmingham – which operates QEHB – are founder-members of Birmingham Health Partners. Fellow BHP members Birmingham Community Healthcare NHS Foundation Trust is an ELSA Study partner.

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New AI tools set to advance early cancer detection and prevention

Written by Louise Stanley on . Posted in Cancer outcomes, Early diagnosis and detection, Health inequalities.

Birmingham researchers are to play a role in Cancer Research UK’s recently announced £10 million AI detection programme, jointly supported by the National Institute for Health and Care Research (NIHR) and the Engineering and Physical Sciences Research Council (EPSRC) and involving 18 institutions including BHP founder-member the University of Birmingham.

Over the next five years, the Cancer Data-Driven Detection programme will harness vast quantities of data, link datasets and develop new tools to predict cancer risk – ultimately increasing the number of people diagnosed with cancer at its earliest stages.

The programme aims to access and link data from different sources – including health records, genomics, family history, demographics, and behavioural data – to develop advanced statistical models that help scientists accurately predict who is most likely to get cancer. Alongside this, the programme will develop powerful new tools which use AI to analyse the data and calculate an individual’s risk of cancer throughout their lifetime.

Researchers from University of Birmingham will take on specific roles in the programme, alongside approximately 40 others working together collaboratively. Professor Sudha Sundar, gynaecological cancer surgeon and a clinical academic in the University’s Department of Cancer and Genomic Sciences, is advising as a clinical practitioner in the multi-cancer risk prediction area of the work. Dr Ameeta Retzer from the Centre for Evidence and Implementation Science will lead on the cross-cutting Equity, Diversity and Inclusion theme, drawing on her expertise in health inequalities and research equity.

Dr Ameeta Retzer said: “Across the whole programme we will work to embed equality, diversity and inclusion since we know that cancer doesn’t affect everyone equally. It is vital that we ensure our research will benefit everyone, across all communities, equitably and that’s why I look forward to ensuring this strand of work has prominence in all areas of the programme.”

Over the next five years, the funding will build the infrastructure required to access and link these datasets, train new data scientists, create the algorithms behind the risk models and evaluate the algorithms and AI tools to ensure that they are giving accurate and clinically useful information about cancer risk.

The models generated from this research could be used to help people at higher risk of cancer in different ways. For example, the NHS could offer more frequent cancer screening sessions or screening at a younger age to those at higher risk, whilst those at lower risk could be spared unnecessary tests. People identified as higher risk could also be sent for cancer testing faster when they go to their GP with possible cancer signs or symptoms. Individuals at higher risk could also access different ways to prevent cancer.

Professor Sudha Sundar, whose clinical practice is based at BHP member Sandwell and West Birmingham NHS Trust, commented: “With cancer cases on the rise, it is essential that we work to identify and diagnose cancers earlier so that patients can begin treatments soon, which in most cancers vastly improves their quality of life and chances of survival. Screening is one way of identifying cancer sooners. Multi-cancer earlier detection tests represent an exciting progression in the scope of cancer screening programmes and this is part of the Cancer Data-Driven Detection programme that is exciting to explore further.”

The scientific programme will be guided by partnerships with cancer patients, the public, clinical experts and industry, while addressing ethical and legal considerations to ensure that the models and tools work well in practice.

Professor Antonis Antoniou, Director of the Cancer Data Driven Detection programme and Professor of Cancer Risk Prediction at the University of Cambridge, said: “Finding people at the highest risk of developing cancer, including those with vague symptoms, is a major challenge. The UK’s strengths in population-scale data resources, combined with advanced analytical tools like AI, offer tremendous opportunities to link disparate datasets and uncover clues that could lead to earlier detection, diagnosis, and prevention of more cancers.

“The Cancer Data Driven Detection programme will build the partnerships and infrastructure needed to make data-driven cancer early detection, diagnosis and prevention a routine part of frontline healthcare. Ultimately, it could inform public health policy and empower individuals and their healthcare providers to make shared decisions. By understanding individual cancer risks, people can take proactive steps to stop cancer before it gets worse or even begins in the first place.”

Earlier diagnosis of cancer saves lives. Yet according to analysis of NHS figures by Cancer Research UK, only 54.4% of cancers in England are diagnosed at stages one and two, where treatment is more likely to be successful. NHS England has set a target to diagnose 75% of cancers at stages one and two by 2028, and this will only be achieved with research and embracing new technologies to catch cancer earlier.

Professor Lucy Chappell, Chief Scientific Adviser at the Department of Health and Social Care (DHSC) and Chief Executive Officer of the NIHR, commented: “Detecting and diagnosing cancer earlier is key to improved survival and quality of life for patients. By leveraging AI to enable healthcare professionals to identify people at a greater risk of cancer, this initiative could improve the way patients are screened and diagnosed. This programme’s AI-driven insights could lead to more effective treatment and improved survival, helping patients to live longer, healthier lives.”

The Cancer Data Driven Detection programme is jointly supported by Cancer Research UK, the National Institute for Health & Care Research, the Engineering & Physical Sciences Research Council, Health Data Research UK, and Administrative Data Research UK.

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Most accurate ultrasound test could detect 96% of ovarian cancers

Written by Louise Stanley on . Posted in Cancer outcomes, Early diagnosis and detection.

An ultrasound test that detected 96% of ovarian cancers in postmenopausal women should replace the current standard of care test in the UK, according to a new study by BHP members.

In a paper published in Lancet Oncology, researchers funded by the NIHR and led by Professor Sudha Sundar conducted a head-to-head comparison of all currently-available tests to diagnose ovarian cancer in postmenopausal women, in a high-quality diagnostic test accuracy study.

Of the six diagnostic tests investigated, the IOTA ADNEX model which looks at ultrasound features (how the lump looks on ultrasound) had the best accuracy of all and could detect up to 96% of ovarian cancers.

The ultrasound test outperforms the current standard of care in the UK significantly and so researchers recommend that the IOTA ultrasound ADNEX model should replace the current standard of care test in the UK which identifies 83% of ovarian cancers.

Sudha Sundar, Professor of Gynaecological Cancer at the University of Birmingham and consultant in gynaecological cancer surgery at Sandwell and West Birmingham NHS Trust – both BHP members – said: “This is the first time that a head-to-head study of all available ovarian cancer tests has been done in the same population. Here we studied their use with symptomatic, post-menopausal women who are most at risk of this cancer. Our trial found that the IOTA ADNEX ultrasound protocol had highest sensitivity for detecting ovarian cancer compared to the standard of care and other tests.

“The ultrasound test also performs well when delivered by a trained sonographer who has received specific training, certification and quality assurance, and as the vast majority of ultrasound scans are performed by sonographers it is important that a new standard is able to be delivered by as many clinical professionals as possible.

“We found that the higher sensitivity of the IOTA ADNEX model is likely to lead to some women who don’t have cancer also being flagged up as having a higher risk of cancer. We however did discuss this extensively with patients, cancer charity Target ovarian cancer and NHS experts who all agreed that in postmenopausal women who are at higher risk of ovarian cancer, picking up more women with cancer would benefit women overall.”

Annwen Jones OBE, Chief Executive at Target Ovarian Cancer said: “Early diagnosis of ovarian cancer is vital, and we are pleased to see this research demonstrate that there are more accurate ways of using ultrasound. The faster and earlier ovarian cancer is diagnosed, the easier it is to treat and the more successful the outcomes. Alongside this innovative research, we need to see greater awareness of the symptoms of ovarian cancer so that women know to come forward to their GP for testing and receive the best possible treatment as quickly as possible. It is crucial that new ways of working like this are rolled out as quickly as possible.”

The research team note that the IOTA ADNEX model achieved 96% accuracy when delivered by NHS sonographers who were appropriately trained and received quality assurance. As most scans worldwide are carried out by sonographers rather than gynaecologists, introductory free online resources have been created by the researchers for NHS staff to undergo the specialist ultrasound training to obtain certification and quality assurance.

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‘Symptom triggered’ test can detect early-stage aggressive ovarian cancer in 1 in 4 cases

Written by Louise Stanley on . Posted in Cancer outcomes, Early diagnosis and detection.

Symptom triggered testing, prompted by symptoms such as pain, abdominal bloating/swelling, and feeling full soon after starting to eat, can pick up early-stage aggressive ovarian cancer in 1 in 4 of those affected, according to new research.

A study published in the International Journal of Gynaecological Cancer and funded by the National Institute for Health and Care Research found that the UK’s protocol for picking up early-stage disease in women with high grade serous ovarian cancer—the most common, aggressive, and lethal form of the disease— is an effective way to diagnose even early-stage ovarian cancer.

The findings also show that complete surgical removal of the cancerous tissue is possible even in more advanced disease, providing that women with suspicious symptoms are expedited for investigation and treatment, they add.

A team of researchers led by BHP founding member the University of Birmingham analysed data for 1741 women taking part in the Refining Ovarian Cancer Test accuracy Scores (ROCkeTS) study, which involves 24 UK hospitals. The women had all been fast tracked for treatment under the symptom-triggered testing rapid access pathway.

Sudha Sundar, Professor of Gynaecological Cancer at the University of Birmingham and the Pan Birmingham Gynaecological Cancer Centre at BHP member Sandwell and West Birmingham Hospital NHS Trust said:

“Our figures demonstrate that in a real-world setting, symptom-based testing can potentially lead to diagnosis of high grade serous ovarian cancer with low disease spread and results in a high proportion of complete surgical removal of the cancer.”

“These findings challenge the assumption that the disease should always be considered to be in its advanced stages in women once they develop symptoms.

“More importantly, our findings emphasise the importance of increasing an awareness of ovarian cancer symptoms to facilitate earlier diagnosis via referral through the fast-track pathway to improve patient outcomes.”

Key findings

  • Among participants in the study, 119 (7%) were diagnosed with high grade serous ovarian cancer with an average age of 63, and 90% had gone through the menopause.
  • In most of these women (112; 94%) cancer didn’t hugely interfere with their daily lives, as they were classified with a performance status of 0 or 1, meaning they either were fully active, or were able to do everything but strenuous activities.
  • One in four (30; 25%) had early stage I or II disease.
  • Visible cancerous tissue was completely removed in 73 (61%) and almost completely removed in 18 (15%). The disease was only deemed to be inoperable in 9 (8%).
  • The extent of cancer was low in 43 of the 119 (36%), meaning that it was localised in the pelvis; moderate in 34 (29%), meaning that it had spread to the lower abdomen; and high in 32 (27%), meaning that it had spread up to any of the liver, pancreas, diaphragm or spleen. Information on disease extent wasn’t available for 10 (8.5%) women.
  • Surgery to remove as much of the tumour as possible, which is associated with longer survival, was carried out in more than three in four women (93 ,78%), with almost two thirds receiving surgery ahead of chemotherapy (78, 65%,). 36 (30%) were given chemotherapy to shrink the tumour ahead of surgery; 5 (4%) women didn’t have surgery, information on this was not available for 17 (14%) women.

The UK adopted symptom-triggered testing for ovarian cancer in 2011. Women, especially those over 50 years with these symptoms are tested for levels of the tell-tale protein CA125 in their blood and given an ultrasound scan. Abnormal results prompt a fast-track referral for hospital review by a gynaecologist within 2 weeks.

Ovarian cancer is the seventh most common cancer amongst women worldwide, and the sixth most common cause of cancer death in the UK. While most (93%) women diagnosed with early-stage disease (I or II) survive for more than 5 years, only 13% of those diagnosed with advanced disease (stages III or IV) do so.

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