HHTU News Roundup

NEWDAY ABC pilot study paper published

The results paper for the NEWDAY ABC pilot study was published in Pilot and Feasibility Studies (https://doi.org/10.1186/s40814-025-01689-3) in August. The NEWDAY-ABC assessed the feasibility of a co-designed weight loss intervention versus standard care in early-stage oestrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer patients. The study was set-up at the start of the pandemic, which presented challenges but intervention was found to be feasible and potentially showed benefit in aiding weight loss and other important health outcomes in women with early-stage breast cancer. A full multicentre randomized controlled trial of the NEWDAY-ABC will start in 2026.

SPOTLIGHT SERIES
02: The BREEZE-2 study

Idiopathic pulmonary fibrosis (IPF) and other fibrotic-interstitial lung diseases, collectively termed pulmonary fibrosis (PF), are progressive, incurable and ultimately fatal. Although two therapies are now available that slow the rate of lung function decline, they have failed to show improvement in symptoms or quality of life. There is limited evidence relating to the efficacy of breathlessness management in people with PF. The poor prognosis, variable disease trajectory and absence of any existing, widely accessible evidence-based treatment to improve patients’ symptoms sets PF apart from other causes of chronic breathlessness

Trial Design

Multi-centre, wait-list design, randomised, controlled trial of a complex, non-pharmacological breathlessness management intervention in people with pulmonary fibrosis (PF) and chronic breathlessness, with embedded qualitative implementation study to inform scaled NHS adoption.

Leadership and collaboration

The study is led by Dr Ann Hutchinson and coordinated by the Hull Health Trials Unit. The Hull Health Trials Unit team is expertly lead by Trial Manager Grant Constable and Data Manager Philip Best.

study progress

The study launched earlier this year, with 14 sites now open and actively recruiting participants. The final 15th site is underway with site set-up and we hope to get them open to recruitment within September.

To date, BREEZE 2 has successfully enrolled 34 participants across nine sites:

· Hull University Teaching Hospitals NHS Trust
· Manchester University NHS Foundation Trust
· NHS Lothian (Edinburgh)
· The Royal Wolverhampton NHS Trust
· Royal Devon University Healthcare NHS Foundation Trust
· University Hospitals of Leicester NHS Trust
· University Hospital Southampton NHS Foundation Trust
· James Paget University Hospitals NHS Foundation Trust
· Western HSC Trust (Northern Ireland)

We sincerely thank all our participating sites for their ongoing commitment and collaboration in driving this vital research forward.

impact and outlook

This study will allow us to test the clinical and cost effectiveness of a complex intervention to manage breathlessness and for us to understand how best to implement the intervention if found to be effective.

Other August project headlines:

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HHTU News Roundup

DOORStep survey collection ended

The DOORStep study is evaluating the effectiveness and acceptability of free door to door transport to increase the uptake of breast screening appointments in Yorkshire. To assess how women travelled to the screening sites they were asked to complete a travel survey. One for women in the intervention arm and one for those in the intervention arm. The survey collection phase of DOORStep has officially ended, and a total of 3696 responses have been collected!

A huge thank you to everyone who participated and helped us gather valuable insights. Work now moves onto the next phases of DOORStep including qualitative interviews and their subsequent analysis.

SPOTLIGHT SERIES
01: The ACESO Study

The ACESO study is a UK clinical trial investigating a promising new treatment approach for acute severe ulcerative colitis (ASUC), a life-threatening flare of ulcerative colitis that often requires hospitalisation and intensive therapy.

Currently, patients with ASUC are treated first with intravenous corticosteroids. However, about half do not respond sufficiently, leading to the use of additional “rescue” therapies or even surgery, including colectomy. The ACESO trial tests whether adding upadacitinib—an effective, fast-acting medication approved for ulcerative colitis—at the start of steroid treatment can improve patient outcomes and reduce the need for further interventions.

Trial Design

This Phase III, randomized, placebo-controlled study plans to recruit 300 participants across approximately 30 UK hospitals. The trial will evaluate if combining upadacitinib with steroids leads to faster clinical response, fewer surgeries, and shorter hospital stays.

Leadership and Collaboration

The study is led by Prof. Shaji Sebastian at Hull University Teaching Hospitals NHS Trust and coordinated by the Hull Health Trials Unit and collaborating with many NHS trusts and academic centres across the UK. The Hull Health Trials Unit team is expertly lead by Trial Manager Mahe Haji Sadeghi and her hardworking team of Trial Coordinators Charlotte Thompson and Paul Bradley as well as skilled Data Managers Beccy Acaster and Sarah Sumpter.

Study Progress

The study launched earlier this year, with 10 sites now open and actively recruiting participants. An additional 10 sites are currently going through the approval (“greenlight”) process to begin recruitment soon, while another 10 are being set up to meet the target of 30 sites. To date, ACESO has successfully enrolled 24 participants across five sites:

• Hull University Teaching Hospitals
• St George’s Hospital
• Royal Devon University Healthcare
• Cambridge University Hospitals
• Kettering General Hospital

We sincerely thank all our participating sites for their ongoing commitment and collaboration in driving this vital research forward.

Impact and Outlook

If successful, the ACESO trial could significantly improve the care pathway for patients experiencing acute severe ulcerative colitis, reducing the burden of surgery and prolonged hospital stays. This trial represents a critical step toward faster, more effective treatment for a condition that affects thousands of people annually.

Other July project headlines:

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HHTU News Roundup

A half year roundup

Unbelievably as we are at the halfway point of 2025, it seems like a good time to reflect on what has been a busy first six months of the year and to look forward to what the next six months has to bring.

The STARLIT programme of work kicked things off in January with the final study report submitted to the NHS Research Ethics Committee and the STARLIT-2 protocol paper published in the BMJ Open. The third STARLIT study opened to recruitment in March with 9 participants consent to date.

Another new study progressing well is BREEZE-2 which opened in March with has 12 site opens and  has recruited 12 participants. The third new trial to open was ACESO which opened April and is already at 12 participants with 6 sites open which is a really positive start.

HHTU Director Judith Cohen gave a presentation to the Hull York Medical School on International Women’s Day detailing the interesting journey her career has taken from A levels to being the Director of HHTU and Co-Lead of the new NIHR Centre for Addictions and Mental Health Research.

Trial Manager Matthew Northgraves secured his first research grant to embed a study within a trial (SWAT) in a HHTU study and also presented to at the UKCRC (UK Clinical Research Collaboration) trial manager operations group ‘Insights for Trial Managers from around the Network’ webinar, one of our previous SWATs. Highlighting some of the methodological work we are doing at the HHTU.

With more new studies in set-up in the second part of 2025 the year promises to continue to be a busy one…

Other June project headlines:

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HHTU News Roundup

TM joins the UKCRC Trial Management Operations Group

Congratulations to HHTU Trial Manager Matthew Northgraves, who has been successful in becoming a member of the UKCRC CTU Network Trial Management Operations Group. The group aims to develop and share best practices to promote high-quality, effective trial management in member CTUs. Matthew becomes the second member of the HHTU currently represented on a UKCRC Operation Group with Information Systems Manager currently the joint chair of the Data & Information Systems Operations Group.

BREEZE-2 has its first recruits

The BREEZE 2 study has successfully recruited its first four patients. These were from sites across the UK including Hull, Southampton and C-TRIC (Northern Ireland).

Trial Manager Grant Constable has worked with Interstitial Lung Disease centers across the UK to get nine sites currently open to recruitment with a further six close behind them.

We’re very excited to get this study on the go and we’re optimistic the BREEZE 2 Intervention will provide relief to those suffering from breathlessness; building on the success of the feasibility study.  You can read more about the BREEZE 2 study here.

Papers published

Two papers have been published in May for studies the HHTU were involved in.

The first paper for EXACQUAL which was published in BJGP Open  (https://bjgpopen.org/content/early/2025/05/04/BJGPO.2024.0026). EXACQUAL was an interview study conducted during the pandemic and explored the experiences, expectations and understanding of exacerbations of COPD patients and their carers before and after the emergence of COVID-19. 

The second was the results paper for the Cognitive Daisy (COG-D) in care homes to support person-centred care feasibility cluster Randomised controlled trial. This was published in Pilot and Feasibility Studies https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-025-01637-1.

HHTU Director Prof Judith Cohen was part of the research team for both and the HHTU provided study management support and data management for the ExacQual Study and the data services for COG-D.

COACH-AC open to recruitment

We are pleased that this month COACH-AC has opened to recruitment. The HHTU are providing the data services for this project. Sarah Sumpter our Senior Data Manager has been working with Dr Philppa Case, the Chief Investigator of this project, to create the electronic data capture database for this study in REDCAP Cloud. As well as this, folders in our secure area of Box have been created for the storage and analysis of other data and the relevant information governance documentation have been completed, reviewed and approved to ensure that the processing is meeting the necessary data protection standards.

Philippa’s study is aiming to understand the prevalence, coexisting conditions and care offered to adults admitted to hospital with coexisting alcohol use disorder and cognitive impairment. Already the team of research assistants in this study have recruited over 40 participants!

If you have a project that, like Philippa’s and COG-D above, requires electronic database or data storage please get in touch with the data team via hhtudatateam@hyms.ac.uk. You can also find more information about the data services we provide here. https://hhtu.hull.ac.uk/our-research/data-services.

Other May headlines:

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HHTU News Roundup

ACESO up and running

We’re thrilled to announce that the ACESO study officially got underway in April! After months of dedicated planning, the team has successfully secured overall study sponsor greenlight and officially opened our first site at Hull University Teaching Hospital.

Even more exciting — our very first participants have now been recruited.

This marks a huge milestone in what promises to be an impactful journey. With plans to open 30 sites across the UK and recruit 300 participants, we’re just at the beginning of an ambitious two-year mission to drive meaningful research forward.

Stay tuned — the ACESO story is just getting started!

HHTU Trial Manager completes the Building Brilliant Leaders programme

Trial manager Matthew Northgraves became the second member of the HHTU to complete the University’s Building Brilliant Leaders Programme. The programme was designed to develop leaders who understand their impact on their people’s wellbeing, who actively create an inclusive culture and who can work with people as individuals to bring out the best in everyone. Matthew said:

“The programme has really highlighted the importance of recognising the needs of the specific individual to ensure you get best out of them whilst creating clear goals for my own future development”.

DOORstep study on the move

We’re pleasede to share the latest progress on the Doorstep Study — and things are moving full speed ahead!

As of the end of April:

✅ 7 GP practices have been randomised, with just one more to go!
🎯 Of these, 4 are in the intervention group and 3 in the control group.

Women registered at the intervention practices are being offered free door-to-door transport to attend their routine breast screening appointments — making it easier than ever to prioritise their health.

📬 So far, over 3,000 women from three participating GP practices have received their screening invitations from the Humberside Breast Screening Service. Among those who attended their appointments, the Doorstep team collected more than 1,600 surveys, marking a significant step forward in gathering meaningful feedback from participants.

We’re incredibly proud of the momentum so far and can’t wait to see the full impact of this innovative, community-driven approach to improving breast cancer screening access.

Stay tuned — the journey continues!

April project headlines:

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HHTU News Roundup

Trial manager presents to UKCRC Trial Manager Operations Group

Trial manager Matthew Northgraves presented at the UKCRC (UK Clinical Research Collaboration) trial manager operations group ‘Insights for Trial Managers from around the Network’ webinar on the 26^th March 2025. With around 100 people in attendance from across the UKCRC network, it was great to see some of the Trials Unit’s methodological work presented more widely. 

HHTU Director presents for International Women’s Day

As a part of the Hull York Medical School celebrations for International Women’s Day, the director of HHTU, Professor Judith Cohen, presented on empowering women in clinical research and paving the path to leadership and inclusion.

Professor Cohen detailed her own career journey, from her A Levels in science and maths to Director of HHTU and Co-Lead of the new NIHR Centre for Addictions and Mental Health Research.

Her interesting presentation discussed gender stereotypes and biases leading to women and girls being discouraged from pursuing careers in clinical research and highlighted the positive action that can be taken to address this gender gap.  These include, engaging girls into science subjects from an early age, creating inclusive workplaces, providing mentorship opportunities and increasing women’s participation in clinical trials. 

Important findings from a DSH project

Dr Ben Pickwell-Smith has used the University of Hull Data Safe Haven (which is managed by Hull Health Trials Unit) to carry out analysis needed for his PhD. His study was looking at whether there are socio-economic inequalities in the diagnosis and treatment of colon and ovarian cancer in England. To do this a successful application was made through the very strict DARs process. This process ensures that we meet very detailed data governance standards and can demonstrate we are able to look after sensitive data. In this study the dataset linked cancer diagnosis information from the National Disease Registration Service (formally National Cancer Registration and Analysis Service) and Hospital Episode Statistics (information about when a person visits hospital) from NHS England (formally NHS Digital) between 2016-2017.

Ben’s research has found that women living in the most disadvantaged areas of the country were 32% less likely to receive surgery and chemotherapy for ovarian cancer compared to those from more affluent areas. Surgery and chemotherapy are the main treatments used in the care of people with ovarian cancer, and those who receive them are more likely to survive. You can read more about Ben’s results in a recent Hull York Medical School article here and read the paper published in Cancer Epidemiology here.

The Data Safe Haven are available to assist with applications to data providers such as NHS England or the National Disease Registration Service. You can email us on DSH@hull.ac.uk to ask any questions or visit out website https://datasafehaven.hull.ac.uk/ for more information.

BREEZE 2 has the greenlight

BREEZE 2 study is investigating a complex, non-pharmacological intervention in adults with pulmonary fibrosis and chronic breathlessness. This intervention includes the use of a handheld fan (provided to patients in this study), breathing control techniques, exercises and activities, managing thoughts about breathlessness and relaxation techniques. The study has gained greenlight this month which means it can start the process of opening it’s 15 sites across the UK.  

Other March project headlines:

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HHTU News Roundup

External funding for Study Within A Trial secured

Trial manager Matthew Northgraves has received a small grant from the University of York. This is to implement a Study Within A Trial (SWAT) in the BREEZE-2 study. A SWAT is a self-contained research study that has been embedded within a host trial with the aim of evaluating or exploring alternative ways of delivering or organising a particular trial process. The study is then replicated in a number of different trials until a decision can be made on whether the intervention works.

New HHTU equality, diversity and inclusion group formed

Within clinical trials there is ever growing awareness that there are people and communities that are underserved by research, a fact recognised by funders. In an attempt increase the inclusivity of our studies, a HHTU Equality, Diversity and Inclusion (EDI) group was formed in February. The group consists of Trial Managers Grant Constable, Amy Wilkinson and Matthew Northgraves along with HHTU Director Prof Judith Cohen and NIHR Doctoral Fellow Laura Hermann. Whilst the first official meeting was not planned until March, meetings have already been held with other supporting networks and courses attended.    

Other project headlines:

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HHTU News Roundup

Productive month in the STARLIT programme of work

January has been a productive month across all three STARLIT studies. The STARLIT (Salivary Test for Adrenal Response to Liquid Intranasal Tetracosactide) programme aims to develop and clinically validate a new needle-free test (the Nasacthin Test) for the diagnosis of adrenal insufficiency.

In STARLIT 1, which looked at the repeatability of blood and saliva cortisol and cortisone levels within the same individual when samples were taken close together, had the final study report submitted to the Research Ethics Committee.

The protocol paper for the follow-on study, STARLIT 2, was published in BMJ Open. The STARLIT-2 study is a healthy volunteer study which is looking to see if the new Nasacthin Test (drug given via a nasal spray and cortisol and cortisone levels measured in saliva) gives comparable results to the standard test, the Short Synacthen Test (drug given using a needle and cortisol measured in blood samples).

Finally, STARLIT 3, which will test the effectiveness of the Nasacthin Test in patients with adrenal insufficiency received sponsor regulatory green light, so is ready to open the study sites to recruitment.

Click here for more information about STARLIT.

PRE-DX has 2 abstracts accepted

The PRE-DX study had abstracts accepted for to the19th St. Gallen International Breast Cancer Conference 2025 in Austria in March and the Association of Breast Surgery (ABS) conference in May.  The abstract for St Gallen is for a poster presentation and the ABS abstract is for an oral presentation and both will be the first dissemination of the study results. 

Other project headlines:

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HHTU 2024 Reflection

Sharing our Research

2024 allowed us to reflect on the growth of the HHTU which has been open 5 years. There was no greater evidence of that growth than our attendance at International Clinical Trials Methodology Conference (ICTMC).

In 2022 we had 1 poster.

In 2024 11 posters were presented.

The 2024 posters were on various topics, including trial methodologies, participant engagement, and innovative approaches to data collection. This year six members of the HHTU were able to attend the event in Edinburgh. ICTMC is a major event for clinical trial professionals, researchers, and the public, providing an opportunity for HHTU to showcase their work. The conference offered valuable learning experiences, with keynote speeches and presentations that enhanced attendees’ research skills. It also provided a platform for networking and collaboration, and allowed attendees to gain insights into the latest developments in clinical trial technology and methodology.

In addition to ICTMC, HHTU staff have presented at several other events, both locally and internationally. Judith presented on the MOI-A Study in Budapest (October) and Bologna (June), while Mahe presented virtually at a conference in Iran (May). Mahe and Charlotte Kelly also showcased a poster at the Annual Allam Lecture in Hull (September).

Working Together

This year, two “away days” were organised, providing a valuable opportunity for teams to come together and discuss important projects and topics. They offered a chance for team members to connect and engage and work together to look at ways to improve procedures and overcome any challenges. The focus was on the Data Team and the Trial Teams, with Operations Manager Bronwen Williams emphasising the value of getting everyone in the same room despite the mix of home and office working.

In addition to these collaborative events, two leaders were recognised as “Brilliant Leaders” this year. The University’s Building Brilliant Leaders Programme is designed to help leaders understand their impact on their teams and foster inclusive environments. Trial Manager Matthew Northgraves, who is currently participating in the course, and Sarah Sumpter, who completed it this year, were the two leaders highlighted. Sarah shared that the programme helped her rethink leadership, boosting her confidence in managing people-related challenges.

As well as this, John Turgoose, a senior team member, was appointed joint chair of the UKCRC Data and Information Systems Operational Group. This appointment reflects the HHTU’s commitment to sharing experiences and collaborating to tackle challenges.

These personal achievements, combined with regular team meetings, contribute to the goal of growing together as a strong and connected team.

A Big HHTU Milestone

A big achievement to end 2024 is that the Hull Health Trials Unit are now a fully registered Clinical Trials Unit after being provisionally registered since 2019.

The UK Clinical Research Collaboration (UKCRC) full registration for clinical trials units (CTUs) is a system designed to assess and formally recognise clinical trials units (CTUs) in the UK based on their ability to deliver high-quality, efficient, and ethical clinical research. This registration is important for CTUs as it provides formal recognition of their capability to manage and deliver complex clinical trials, particularly those that involve public funding or collaborations with other research entities. Achieving UKCRC Full Registration is an indicator that a CTU is capable of managing large, complex trials with a high standard of professionalism, compliance, and research integrity. It reflects a commitment to conducting research that can impact public health and clinical practice, and often signals that a CTU is capable of working with various stakeholders, including academic institutions, hospitals, government bodies, and pharmaceutical companies.

We have no doubt that 2025 will be another year of growth with more collaboration, dissemination and achievements to come.

All at HHTU would like to wish all our colleagues and collaborators a restful Christmas Break and a very Happy New Year.
The HHTU will be closed from 5pm Friday 20th December until 9am Thursday 2nd January.

HHTU News Roundup

First Trial Management ‘Away Day’

On Wednesday 13^th November we held our first Hull Health Unit Trial Management ‘away day’ (even though it was in the office). Since opening in 2018, the HHTU has continued to grow with the team ever expanding so this was a chance to get all the trial management team together. It was a great day of discussions and shared learning around potential recruitment and retention strategies, risk assessments and monitoring.

Operations Manager Bronwen Williams said ‘Now we are all working from home and the office, it was great to get everyone in one room (except for Mahe who joined remotely). We had a very productive meeting including training, discussions on emerging issues in clinical trials and how we might implement key trial management initiatives. It was a positive and productive day, and we have agreed to have ‘Away Days’ at least twice every year going forwards.’

HHTU Director and Trial Manager attend Networking Event

Our Director Judith Cohen and Trial Manager attended the joint Innovation, Research and Improvement System (IRIS) at Humber and North Yorkshire and NIHR ARC Yorkshire and Humber knowledge motivation networking event. It brought together in bringing together individuals from academia, the Integrated Care Board and Integrated Care Systems with the NIHR infrastructure in the region. This promoted the sharing of knowledge which is important for moving research evidence into practice and led to future collaborations to be discussed.