Under the leadership of Professor Peter Sasieni, the Cancer Research UK Cancer Prevention Trials Unit (CPTU) at QMUL, stands as one of eight CRUK core funded UK Clinical Trials Units (CTUs). The CPTU is at the forefront of advancing cancer prevention, pioneering early diagnosis and transforming screening practices to save lives and improve outcomes.
The unit’s research aims to improve the efficacy, cost-effectiveness and technologies for existing screening programmes while also developing innovative new screening initiatives. Our portfolio encompasses trials conducted in both secondary (hospital-based) and primary (community-based) care trials, including:
The CPTU core team provides a comprehensive Quality Management System (QMS), alongside statistical support and expertise in the design, management and governance of pilot, feasibility and phase III clinical trials focused on cancer prevention and screening. Additionally, the team provides mentoring, training and management support for trial-specific staff. By exploring advances in design and infrastructure, the CPTU continually seeks to improve trial efficiency.
We also offer specialist advice to trial-specific staff, collaborators and participating centres on national and international standards for the conduct of clinical research, covering:
If you require CPTU services for your study, we provide oversight of key trial activities, including:
If you would like to seek our advice or collaborate with us on a study, please contact us at cptu-management@qmul.ac.uk. We encourage you to reach out early in the grant application development process to maximise our support and enhance the success of your application.
CRUK Cancer Prevention Trials Unit (CPTU) Core funding award - CRUK CRC Clinical Trials Unit – renewing Program Award April 2023
This early detection programme for Barrett’s oesophagus (BO) and oesophageal cancer (OAC) involves a Screening Trial and a Surveillance Trial.
The BEST4 Screening Trial will assess whether a minimally invasive diagnostic test involving a capsule sponge can reduce the number of deaths due to OAC deaths when offered as a ‘screening’ test to individuals who regularly take medication for heartburn. The Screening study will recruit 120,000 participants, of whom 40,000 will be screened using a capsule sponge on mobile units located in four UK regions. The BEST4 Screening Trial is open and recruiting.
The BEST4 Surveillance Trial investigates Cytosponge as a primary monitoring method instead of endoscopy in patients with non-dysplastic BO. The Surveillance study will offer 1,900 participants monitoring or surveillance with Cytopsponge, coupled with additional lab biomarker tests, to see if endoscopy could be avoided in their future follow-ups. The BEST4 Surveillance Trial is currently open and recruiting. For further information, please refer to the BEST4 website.
Prostate cancer is the most common cancer in men, yet many prostate cancers are not life-threatening and can be safely monitored, rather than treated immediately. This management is known as Active Surveillance, (AS). FINESSE investigates whether Finasteride, a drug used to slow prostate growth, can reduce the need for surgery or radiotherapy in men with early prostate cancer.
The trial will randomise men already on Active Surveillance for low/intermediate risk prostate cancer to either receive finasteride and their usual care, i.e. AS, or usual care only. All participants will remain on Active Surveillance, which includes regular PSA testing and MRI scans at intervals based on local practice.
Typically, PSA tests are conducted every three months in the first year, and every six months in the second and third years. MRI scans are usually performed in the first and third years. Prostate biopsies will be conducted for men with changes in their MRI results, or at year three if recommended locally.
FINESSE is currently open and recruiting. For further information, please visit the FINESSE website.
Yorkshire has some of the lowest survival rates from bladder cancer in Britain. Improving early diagnosis through targeted screening could significantly enhance survival outcomes for high-risk individuals.
YORKSURe investigated the best method for identifying and testing for bladder cancer. The study investigated the reliability of urine self-testing in bladder cancer in three cohorts.
1) Self-testing in the YORKSURe Lung Screening Trial: 2,000 screen-engaged participants already enrolled in the Yorkshire Lung Screening Trial self-tested their urine for blood. Those with positive results were invited to attend local screening clinics for further tests (urine cytology and ultrasound), with treatment provided at local hospitals for those diagnosed with cancer.
2) Home urine dipstick testing for men: 3,000 male participants, recruited from GP Practices across the Yorkshire region received home urine dipstick tests to self-test for blood or glucose in their urine up to six times. Those with positive results were invited to attend local screening clinics for further tests (urine cytology,ultrasound or a blood glucose test), with treatment provided at local hospitals for those diagnosed with cancer.
3) Follow up of NHS patients on the 2WW (Two Week Wait) pathway: 500 NHS patients currently being investigated for bladder cancer were sent urine dipstick tests to their home to self-test for blood. They were then followed up until diagnosis.
YORKSURe is currently undergoing final analysis.
Developed by GRAIL, the Galleri® test is designed to detect early-stage cancers through a simple blood test. This pioneering programme was piloted in 2021 as part of a research study in collaboration with NHS. Over 140,000 asymptomatic participants, aged 50 to 77, were identified through NHS records, invited to take part and recruited to undergo annual blood tests at baseline, year one and two. Participants with a positive test result were referred to the NHS for further investigation.
The Galleri® test could support the NHS Long Term Plan goal of increasing the proportion of cancers detected early - key to reducing cancer mortality. Patients diagnosed at ‘stage one’ typically have a five to ten times higher chance of surviving compared to those diagnoses at ‘stage four’.
The NHS Galleri trial is currently in the monitoring phase before analysis. For further information, please refer to the NHS Galleri website.
Self sampling has the potential to change cervical screening by addressing declining participation rates and reducing inequalities in many organised screening programs.
The YouScreen trial provided self-sampling for HPV testing to women and people with a cervix who were at least six months overdue for their cervical screening, to estimate the uptake and potential increase in coverage with offering self-sampling. YouScreen marked the first-time self-sampling was offered with the NHS cervical screening programme and was the largest trial of self-sampling for cervical in the UK to date.
Kits were offered to over 27,000 un- and under-screened women and people with a cervix by 133 participating GP practices in 5 CCGs in Northeast and North Central London (Barnet, Tower Hamlets, Newham, Camden, Islington). provide the evidence base for the implementation of offering self-sampling to cervical screening non-attenders. Over 8,000 participants returned self-sample kits. Results published in the Lancet found offering self-sampling kits to under-screened women posting kits to women’s homes or offering self-sampling kits where they attended their GP practice could boost the numbers screened in England by about 400,000 each year.
Under screened women are at the highest risk of developing cervical cancer, yet the number of women attending cervical screening continues to fall. A potential solution is to offer self-sampling for HPV (human papillomavirus) testing.
ALOHA was a randomised-controlled pilot trial conducted at 13 GP practices in London within the Hounslow Clinical Commissioning Group (CCG), involving 8,420 participants. GP practices were randomised 1:1 to either the intervention arm (offering self-sampling kits opportunistically to women overdue their cervical screening by >6months during GP visits) or the control arm (control arm).
Within each practice, women were further randomised in a 2:1:1 ratio to one of three groups:
The pilot study data is being analysed and will calculate measures of feasibility and acceptability such as the proportion of eligible women who are offered kits, accept and return a self-sample following each intervention.
The capsule sponge test improves detection of Barrett’s oesophagus, an oesophageal cancer pre-cursor, in people with heartburn/reflux. Trial participants have reported high acceptability; however, the psychological/behavioural impact of capsule sponge screening haS not been thoroughly investigated.
SPOTLIGHT aims to investigate the psychological impact of reflux and capsule sponge test screening as a nested study within the BEST4 Screening trial. To understand and compare psychological outcomes, over 6,000 participants will be recruited from four groups: control, normal screening results, abnormal screening results with no Barrett’s found, and abnormal screening results with non-dysplastic Barrett’s or oesophageal cancer found. Participants will be asked to complete three surveys over one year in the study.
The study is currently in set-up with recruitment scheduled to commence next year.