Clinical Research at SWFT

Research Governance

Associate Medical Director of Research

Head of Research & Development

Email: Research@swft.nhs.uk Twitter: @Research_SWFT

Core Research

Senior Research Nurse

Email: Research.Nurses@swft.nhs.uk

Cancer Research

Rigby Lead Nurse – Cancer Research

Email: cancerresearch@swft.nhs.uk Twitter: @CancerWarwick

Family Health Research

Lead Research Midwife

Email: ResearchMidwife@swft.nhs.uk

The clinical benefit of undertaking cancer research includes access to the most novel and innovative cancer therapies. It has led to new drug treatments, a greater understanding of how to prevent cancer, new ways of delivering treatments and new surgical techniques. Cancer clinical trials are critical to advances in the understanding and treatment of cancer and to ensure patients have the opportunity to access world-class cancer treatments.

There is evidence to suggest that clinical research activity is a driver for high-quality cancer care with better outcomes for patients who are treated in research-intensive hospitals (National Institute for Health Research, 2014).

We have highlighted three of our current trials below:

TROPION-Breast02 is recruiting patients with previously untreated triple negative breast cancer (TNBC) that has spread (metastatic) or TNBC that has come back and cannot be removed. This international AstraZeneca Phase III study is assessing whether a new treatment, datopotamab deruxtecan (Dato-DXd), is better than current treatments. TNBC affects 1 in 5 women with breast cancer and is more common in women <40 and black women. It is the most aggressive type of breast cancer and cannot be treated with hormonal or targeted therapies. The outcome for patients with metastatic TNBC is usually worse than other types of breast cancer, with overall survival generally less than two years and five-year survival around 12%. Current treatment options may be poorly tolerated by patients and reduce quality of life. Dato-DXd is an antibody-drug conjugate, a treatment that can target breast cancer cells and deliver a drug that stops the cells growing. Warwick Hospital is offering the promising new treatment to patients across The Midlands.

Myeloma XV (RADAR) is recruiting patients newly diagnosed with Multiple Myeloma (MM) who are able to have a stem cell transplant. MM, also known as Myeloma, is a cancer that affects the bone marrow, spongy tissue found inside some bones that produces blood cells. Over 5,500 patients are diagnosed with MM each year in the UK. MM is an incurable relapsing-remitting cancer, meaning there are periods where the disease is active (relapsing) and requires treating, followed by periods where treatment may not be required (remitting). Significant progress has been made in developing new lines of treatment over the past 15 years. Newly diagnosed patients now survive on average 5-6 years, with 37% of men and 28% of women surviving 10 years. Currently all MM patients are given the same treatment, this UK-based Phase III study is investigating the personalisation of MM care. Some patients will have genetic markers that suggest their cancer will be more difficult to treat. These higher-risk patients, along with those whose cancer has not responded well to initial treatment, are offered more intensive therapy to extend the remitting period, while lower risk patients can receive reduced treatment with the aim of reducing side effects.

However, some women are at higher risk of becoming resistant to these treatments. Poetic-A is a phase III multicentre trial that assesses whether a new drug, abemaciclib, can be given to make treatment more effective than giving ET alone. This will aim to personalise care by looking at biological markers of risk, such as Ki67, to target treatment for women who are less responsive or resistant to ET and are therefore at higher risk of breast cancer coming back.

We are also recruiting to the following trials: COSMOS (Smouldering Myeloma), Cutaneous Tumour (Keratoacanthoma), Mithridate (Polycythemia vera), Nerlyfe (early-stage HR+/HER- breast cancer being treated with Neratinib), Rampart (Renal Cell Carcinoma), Rudy (AML), Stampede (Metastatic/Advancing Prostate Cancer), TransRampart (Renal Cell Carcinoma), UKGPCS (Prostate Cancer) and UKAITPR (Idiopathic Thrombocytopenic Purpura). For more information visit Be Part of Research or contact us directly.Oncology and Haematology Trials

GBS3 trial is looking at whether testing pregnant women for Group B Streptococcus reduces the risk of infection in newborn babies compared to the current strategy in place in the UK. The current strategy in the UK is to offer antibiotics during labour to women who are considered at raised risk of their baby developing a group B Strep infection.

There are two different tests, which the study is comparing against the current strategy. Hospitals are randomly allocated to 1 of 3 groups:

• Lab Based Test at 3-5 weeks before anticipated delivery date (Enriched Culture Medium Testing)
• Bedside Test at start of labour (Intrapartum Rapid Testing)
• Risk Factor Based testing (Usual Care)

SWFT has been randomised to the Risk Factor Based testing group. This means no additional procedures (outside of the usual care) will be undertaken. Women will be treated for group B Strep in accordance with SWFT hospital policy and the current UK strategy.

The Giant PANDA Trial is looking at evaluating the effects of different antihypertensive drugs in women with pregnancy hypertension on maternal and foetal/neonatal outcomes.

The study is a randomised control trial, which means women who want to take part are randomised into one of two medication groups, both of which can be used to treat raised blood pressure in pregnancy.

The aim of the trial is to identify which is the most suitable medication to use, therefore the Research Midwife team at SWFT will follow the participant’s pregnancy and birth, providing anonymised data to the trial team. If the medication that the participant is randomised to isn’t working to treat their raised blood pressure, they can be reverted back to the alternative medication.

CRAFT-OBS is a study run by Kings College London. The aim of the study is to understand the association between the degree of cervical dilatation at caesarean section in labour, with the risk of late miscarriage or pre-term birth in subsequent pregnancies.

Women who are less than 37 weeks pregnant and who have had a previous term caesarean section in labour are invited to participate in this observational study.

Data around pregnancy and birth of these women is collected by the SWFT Research Midwife team and anonymised on the national database, to help the study team identify if there is an association between previous caesarean sections in labour and preterm birth in a future pregnancy.

Perioperative Quality Improvement Programme (PQIP)

PQIP is a national research and quality improvement initiative which is looking at the perioperative care of patients having elective surgery. The aim is to investigate how these patients are treated, how they feel their care and recovery has been and if any complications have occurred. This data can then be used to improve patient care and ensure best practice is maintained throughout the whole country.

Here at Warwick Hospital, we have successfully recruited over 250 colorectal patients to the study.

For more information go to www.pqip.org.uk

SQUEEZE-UK

The SQUEEZE-UK study

In June 2022 we opened the SQUEEZE-UK study. This study is looking at postoperative use of a medication type (vasopressor) to maintain a patient’s blood pressure and the relation to developing atrial fibrillation (AF) an irregular heart rhythm.

Some patients during surgery develop abnormally low blood pressure, sometimes requiring the need of a vasopressor medication. This often leads to an intensive care stay and possibly prolonged hospital stay leading to increased risks of developing complications.

This is a two part study, cohort A data collection of all non-day case surgical patients taking place as a “snapshot” over 7 consecutive days this will help determine the proportion of patients receiving vasopressors and developing AF.

Cohort B will recruit a further 30 patients who develop low blood pressure and require vasopressors with a more in-depth data collection.

To date we have recruited 85 patients in Cohort A and 19 patients for Cohort B.

SQUEEZE-UK will then be analysed as part of the worldwide SQUEEZE study

OPTIMISE Study

Research Question: Can we predict which patients with Psoriatic Arthritis will respond to treatment using precision medicine?

This study is supporting patients with Psoriatic Arthritis who do not respond to standard arthritis drugs. There are two different types of biologic drugs available (Adalimumab and Secukinumab).

In patients taking either of these drugs about 50 % will find the drug relieves their symptoms, however importantly 50 % will not respond well. Trying each drug can take time and patients have to wait to see if another drug works.

We do not currently know how to predict in advance which patient will respond best to each drug. The study aim is to test whether we can predict, using blood tests, if people with Psoriatic Arthritis will respond to either biologic drug leading to a reduction in inflamed joints and pain.

The Surviving Crying project was created to support parents and carers who have babies up to five months old who cry for prolonged periods. Excessive crying affects one in five babies, with peak crying often happening around five weeks of age. This is sometimes known as infant ‘colic’, although it often has nothing to do with digestion or any physical illness.

The project team has developed a support package to help parents understand and cope with prolonged crying, which can be extremely traumatic for parents and carers. This includes written and online materials and a support programme provided by specially trained health visitors.

This trial aims to find out if our support package used in conjunction with standard health visits is more effective in helping parents and carers cope with an excessively crying baby than standard health visits alone.

LISTEN

Individuals with long COVID experience a wide variety of ongoing problems such as tiredness and difficulty with everyday task, meaning they can struggle to return to their former lives. This is then made worse by uncertainty and a lack of understanding by some healthcare professionals.

The LISTEN team are evaluating a co-designed, personalised support package intervention to help others living with long Covid to self-manage their condition. The aim is to compare this intervention with usual care in the NHS to see whether it can help people manage long Covid symptoms in everyday life.

This project takes 24 months. In the first six months people living with or have recovered from long COVID, and rehabilitation practitioners will be recruited to a ‘LISTEN Co-design’ group, helped by ‘Diversity and Ability’ who have expertise in reaching seldom heard populations. They will use different activities such as online groups to design their intervention to include a book, digital resources and a new training package for rehabilitation practitioners to enable them to deliver the intervention.

Fast Track Faecal Calprotectin

Changes in bowel habits are common in the general population. The Fast Track Faecal Calprotectin Study aims to collect information from patients referred from primary care with fast track lower gastrointestinal symptoms, who have been recommended for further investigation of their bowel symptoms, or who are scheduled for routine bowel surveillance, such as a colonoscopy, a CT colonography, or a Colon Capsule Endoscopy (which is being piloted by the NHS) to compare the three different tests to see how effective they are at identifying bowel disease.