Current Research

Research is actively promoted in our Paediatric and Neonatal areas and we have a wide range of studies covering various specialties from Respiratory, Orthopaedics, Dermatology and Endocrinology.  

If you would like to find out more, please call 01270 612123.

What is a Clinical Trial? - a short video for parents and children

https://twitter.com/SCIENCEtrial/status/1309499894936334337

Open Trials

The BADBIR research study is an observational study looking at treatments used for patients with psoriasis.

The ADDRESS-2 project is for children and adults newly diagnosed with type 1 diabetes wanting to hear about opportunities to take part in clinical research. 

GenOMICC studies the genes (DNA) of people who become critically ill, or meet certain criteria, to better understand why some people become sicker than others and, potentially, to discover new ways of treating patients. More info can be found at www.genomicc.org

Cytomegalovirus, or CMV, is a common virus that can infect people of all ages. CMV can pose serious problems to unborn babies if a woman catches the virus in pregnancy. The aim of the study is to gather information about children born with CCMV in the UK, including identifying risk factors for children who have long term problems, such as hearing loss, and to see which tests may be able to predict these problems early on. We will also monitor the side effects of treatment. We hope this study will support the future development of new strategies and therapies for better treatment and prevention of CCMV.

B-STOP- Biomarkers of Systematic Treatment Outcomes in Psoriasis

This study can only be offered to patients who are participating in the BADBIR study. The overall research aim of this large, multi-centre study is to discover which gene(s) and other so- called ‘biomarkers’ (for example present in blood sample) are important in determining good (or poor) responses to the drugs that are used to treat psoriasis.

The Impact of the COVID-19 Pandemic on the Timing, Age and Severity of Respiratory Syncytial Virus (RSV) Emergency Presentations
A Multi-Centre Prospective Observational Study

The 2024-2025 season is also capturing maternal immunisation data for babies born after 01/09/2024 for RSV vaccine uptake surveillance.

If you require any more information, please contact joanne.tomlinson@mcht.nhs.uk

Trials no longer recruiting but still collecting follow-up data:

Aztec 2

CFSTART

CRAFFT

BLIPA

Leighton Hospital’s Surgery and Cancer Research Department is actively involved in clinical research and has many studies currently open to recruitment across seven different disease areas.

If you would like to know more about getting involved in any clinical research in any of these areas please contact the Surgery and Cancer Research Department on 01270 273486 or email oncologyandsurgeryresearch@mcht.nhs.uk

OPEN TRIALS

BREAST

A clinical study for people with early stage breast cancer which has spread to the axillary nodes. Breast cancer sometimes spreads to other areas of the body via the lymphatic system. Chemotherapy can be given as a first treatment to target these cells and reduce cancer in the axillary before surgery. After chemotherapy , further treatment to the axillary is usually offered to everyone which may include surgery or radiotherapy. This extra treatment can cause additional side effects like lymphedema and shoulder problems. We are investigating whether the extra axillary treatment is necessary for all patients to ensure we offer patients the best treatment with the fewest side effects.

Optimal Personalised Treatment of early breast cancer using Multi-parameter Analysis

Chemotherapy is only offered to some patients with oestrogen receptor (ER) positive and HER2 negative disease.  People with this type of breast cancer are often advised to have chemotherapy. Research suggests however, that not all people will benefit from chemotherapy.  Some may do just as well with hormone treatment alone. The aim of the trial is to improve decision making so that chemotherapy is only given to those people who could benefit from it.  Tests have been developed to try to improve decision making. These tests tell us about how a tumour may behave in the future.  The tests use a sample of the tumour already removed by the surgeon.  The trial wants to find out whether we can use one of these tests to safely and effectively make decisions about who should have chemotherapy.  Everyone who takes part in this study will receive hormone therapy.

PROSTATE

The causes of prostate cancer are unknown and the study aims to recruit 26,000 men to discover why prostate cancer develops. The research will involve studies investigating the causes of prostate cancer and factors that are associated with how the disease behaves and the effects of treatment. In particular, the study will be looking at the causes of prostate cancer developing in young men and those with a family history. The study also hopes it will help to understand the cause of the disease in patients who do not necessarily have a family history. 

COLORECTAL

To examine whether a Complex Intervention protocol decreases Toxicity in patients following Radiotherapy or Surgery for colorectal cancer. The primary objective is to assess the feasibility of collecting electronic Patient Reported Outcome Measures (PROMs) in patients with a diagnosis of colorectal cancer. We are looking at the use of electronic data to identify symptoms and symptom clusters amenable to intervention and develop interventions which can be delivered electronically.

FOXTROT2

A phase III trial of neo-adjuvant chemotherapy in older and/or frail patients with locally advanced but resectable colon cancer.

To assess and compare whether 6 weeks of NAC with oxaliplatin/fluoropyrimidine (OxFp) followed by surgery will improve disease free survival (DFS) and short-term safety and efficacy outcomes in frail and/or older patients compared with straight to surgery (STS). All participants will be followed up pre & post NAC and pre & post-surgery.  Recurrence events will be collected on annual follow up reports.

FOXTROT3

A randomized phase III trial of neo-adjuvant chemotherapy with mFOLFOXIRI compared with neoadjuvant OxFp in patients with locally advanced but resectable colon cancer. To assess and compare whether 6 weeks of NAC with mFOLFOXIRI followed by surgery will improve the proportion of patients with a pathological response to NAC (as assessed in the surgical resection sample) according to tumour regression grade (TRG), disease-free survival (DFS) and short-term safety and efficacy outcomes compared with 6 weeks of NAC with OxFp followed by surgery.  All participants will be followed up pre & post NAC and pre & post-surgery.  Recurrence events will be collected on annual follow up reports.

TRACC

Tracking mutations in cell free tumour DNA to predict Relapse in eArly Colorectal Cancer. To demonstrate a de-escalation strategy of ctDNA guided

adjuvant chemotherapy is non-inferior to standard of care treatment as measured by 3 year disease free survival in patients with high risk stage II or stage III colorectal cancer with no evidence of minimal residual disease (ctDNA negative).

SURGICAL

PI Dimitrios Kyriakidis

ROSSINI2 stands for "Reduction Of Surgical Site Infection using several Novel Interventions 2".  The overall aim is to see if using different interventions during abdominal (tummy) surgery will reduce the chance of a patient getting a surgical site infction.

Open to recruitment.

“Perioperative” refers to the time before, during and after surgery. Our aim is to improve the care and treatment of patients undergoing major surgery in the United Kingdom. We do this by collecting and studying information about you, your surgery, and then your recovery afterwards.

POPPY

Patient reported outcomes, postoperative pain and pain relief after day case surgery for adults undergoing day-case surgery in the UK. Short-term: to describe the quality of recovery over the first postoperative week. Long-term: to establish the prevalence of persistent postsurgical pain (PPSP) and persistent postoperative opioid use (PPOU) in day case surgical patients. Follow up duration 90 day.

Trials no longer recruiting but still collecting follow-up data:

MAMMO-50 (Observational non RCT)

MAMMO-50

PATCH

Persephone

PRIME II

MARVEL

POETIC

IMPRESS

POSNOC

B-AHEAD3

True NTH UK Post Surgical Follow up

PRIMETIME

ESPAC-4

E-PATH

BOSS

SUPREMO

NSCCG

IMPORT HIGH

ACE

BEST BRA

STAMPEDE

ADD-ASPIRIN

SNAP2 Trial

A randomised controlled trial, looking at the impact of the ‘Baby, Me & NRT’ intervention on pregnant women’s adherence to nicotine replacement therapy (NRT)

Primary objective: To determine whether the ‘Baby, Me & NRT’ intervention added to usual NHS cessation support increases pregnant women’s number of days of NRT use in the first 28 days following a quit date.

SNAP3 Trial

Open-label randomised controlled trial of enhanced support and nicotine replacement therapy (NRT) offered for preloading, lapse recovery and smoking reduction: impact on smoking in pregnancy

The purpose of the study:

We are looking to optimise the use of Nicotine Replacement Therapy (NRT) as a smoking cessation aid during pregnancy.  NRT, such as nicotine patches, contains nicotine, but is free from harmful chemicals found in cigarettes.  Using NRT is safet than smoking and it reduces the urge to smoke and can make it easier to stop smoking.

• Stopping smoking in pregnancy is one of the best things a woman can do for her baby's health.
• The NHS offers NRT for free to pregnant women to help them stop smoking.
• This study is testing whether some new ways of using NRT can help women to stop smoking and could improve women's and babies' health.

Multiple Pregnancy Register

To systematically track complicated multiple pregnancies, and uncomplicated monochorionic twin pregnancies, to ascertain pregnancy outcomes and address the gaps in knowledge.

To improve patient care by following the best scientific evidence.To provide complete data for quality benchmarking projects, audits and research studies.

To establish a platform to allow long-term follow-up of these infants at a national level. The Registry would facilitate long-term follow-up of a large cohort of twins whose pregnancies were complicated, whether or not they had antenatal intervention.            

Mothers Working to Prevent Early Stillbirth Study 20-28

The study’s principal objectives are:

1. To conduct structured interviews with bereaved mothers/parents or pregnant people to gain a deeper understanding of potentially modifiable risk factors which affect their baby’s risk of early stillbirth
2. To describe associations of potentially modifiable risk factors for early stillbirth according to different causes of early stillbirth.

PREterm birth genomic investigation using whole Genome sequencing.

Using whole genome sequencing (WGS), the study aims to identify genetic determinants which lead to spontaneous preterm birth (sPTB).

Approximately 10% of global pregnancies are affected by sPTB, this amounts to 53,000 cases in the UK.  It is the leading cause of infant mortality globally. A fuller understanding of genetic/biological factors that predispose to PTB will assist in developing strategies to reduce the impact of PTB on the health of affected mothers and children.

PARTICIPANTS

Biological parents (over 18 years old) who had a preterm birth (between 16+0 and 36+6 weeks of gestation) in current or previous pregnancies and children (under 5 years old) born preterm with various ethnic backgrounds across England.

Katrina Humphreys is the Physiotherapy Research Facilitator for CCICP MSK studies.  She works half time in research and half time in physiotherapy – where her main time is spent as a Vestibular Specialist Physiotherapist.  Katrina can be contacted at katrina.humphreys2@mcht.nhs.uk

The studies active in CCICP are:

FEMUR 111

This is a Fractured Neck of Femur study – consenting adults over the age of 60 that are admitted to Leighton Hospital with a fractured neck of femur and are then taken to surgery for a repair.

The eligible patients are identified and then asked if they would mind a study team member contacting them when they are discharged home.

If they consent to the study they are then randomised to either the “usual care” arm OR the “enhanced care” arm.

This enhanced care involves 6 visits to the patient’s home to provide physiotherapy rehabilitation over a period of 17 weeks.

PROP-OA

This is a study consenting patients over the age of 45 with osteoarthritis of the knee. This is looking at whether good quality advice and exercises OR that PLUS bracing is more effective for osteoarthritis of the knee.

These patients will be attending the physiotherapy department for an assessment by a physiotherapist and then possibly an X-Ray if needed. Once they are deemed eligible they are booked for a consent and randomisation slot and a treatment time.

These patients then receive their intervention and if they are in the bracing arm of the study they will then have another appointment for a brace check.

A second site has also been opened at Victoria Infirmary.

Medical and Emergency Care (MEC) Research Team

The MEC research team delivers both commercial and non-commercial research for Respiratory medicine, Rheumatology, Cardiovascular disease, Gastroenterology, Anaesthetics as well as some Surgical studies. Business as usual research activity was paused locally and nationally in March 2020 due to the pandemic and, in collaboration with a multidisciplinary team, MEC have led and delivered the Urgent Public Health Research portfolio.  A tentative restart of business-as-usual research has now commenced.

Current Studies:
 

PI Dr J Majumdar; Lead CRN Claire Gabriel

This randomised control trial is looking at different treatments for Covid which currently include:

• High dose Corticosteroids
• Sotrovimab
• Oseltamivir (an antiviral treatment)
• Baloxavir (an antiviral treatment)
• low dose corticosteroids

Treatments that have been proven to work include:

• Dexamethasone reduces risk of death by a fifth in those on oxygen.
• The IL-6 inhibitor Tocilizumab reduces the risk of death by a further seventh
• Neutralising monoclonals can reduce the risk of death by a further fifth in seronegative patients.

Almost 500 patients have been recruited and randomised to the RECOVERY trial at MCHT.

Open to recruitment.

PI Dr Kalman Pencz / Holly Maguire (Advanced Nurse practitioner for Stroke) and supported by MEC research team.

OPtimal TIMing of Anticoagulation after Stroke (randomised control trial).

OPTIMAS will investigate whether early initiation of DOAC treatment, in patients with acute ischaemic stroke and AF is as effective as, or better than, standard initiation of DOAC treatment.

Open to recruitment.

PI Dr Richard Lowsby; Lead CRN Claire Gabriel

Sepsis is a common life-threatening condition that is triggered by infection. In sepsis, the body’s defence mechanisms (immune system) react excessively, resulting in widespread inflammation and swelling. If not treated quickly, sepsis can result in shutdown of vital organs which can result in death. Each year in the UK, about 200,000 people develop sepsis and up to a quarter will die. Previous research indicates that early recognition of sepsis and rapid antibiotic treatments are the most important factors for patient survival. While starting antibiotics for sepsis is crucial, the recommended duration of such treatment is uncertain. The lack of research on when to stop treatment safely can lead to an overuse of antibiotics in this condition. Antibiotic overuse is important because it promotes bacteria that are resistant to antibiotics (antimicrobial resistance).

Open to recruitment.

GenOMICC studies the genes (DNA) of people who become critically ill, or meet certain criteria, to better understand why some people become sicker than others and, potentially, to discover new ways of treating patients. More info can be found at www.genomicc.org

Open to recruitment.

The Metoclopramide for Avoiding Pneumonia after Stroke (MAPS-2) Trial

Pneumonia is a major cause of death after stroke and delays recovery in survivors.  It is likely to occur in stroke patients who have problems swallowing.  The purpose of this study is to test whether the drug metoclopramide can prevent death and pneumonia in patients who have had a stroke.

Open to recruitment.

Tranexamic acid for Hyperacute Spontaneous Intracerebral Haemorrhage (TICH-3)

The purpose of this study is to see if the drug tranexamic acid reduced the bleeding in this type of stroke and if it may reduce the severity of injury caused by the stroke.

Open to recruitment.

Pharyngeal Electrical stimulation for Acute Stroke dysphagia Trial (PhEAST)

The purpose of this study is to find out whether a regular course of treatment of Pharyngeal Electrical Stimulation (PES), stimulation of nerves in the throat that may have been damaged by a stroke, can help recovery back to eating and drinking by mouth.

Open to recruitment.

Trials no longer recruiting but still collecting follow-up data:

L-Harp

Serena

Ophthalmology Research

Leighton Hospital’s Ophthalmology Department is actively involved in research. The two studies currently open are important in helping us to better understand how to diagnose, treat, cure or prevent age-related macular degeneration. In the coming months we will be expanding our portfolio to include areas of dry eye, glaucoma and cataract research studies.

If you would like to know more about getting involved in any clinical research in this area please contact Advanced Nurse Practitioner Lisa Rudy Fitzgerald on bleep 3451 (accessed via main switchboard 01270 255141).