CURRENT TRIALS
Cancer Prevention for Indolent Cancers and Pre-Cancers
FINasteride Evaluation in Surveillance for proStatE cancer trial (FINESSE)
Prostate cancer is the commonest cancer in men, yet many prostate cancers are not lethal and can be safely managed by observation (Active Surveillance). Over time, more than half of the men choosing observation receive radical surgery or radiotherapy. Both treatments produce side-effects and may be unnecessary. Most men opt for treatment because of their rising PSA (prostate blood test) levels; this usually reflects aging of the prostate, rather than advancing cancer. This research aims to investigate a drug called Finasteride to explore if it will help more men to remain on observation. slows prostate growth and reduces PSA levels. 550 men receiving observation for low/intermediate risk prostate cancer will be randomly allocated to receive finasteride or usual care. All men will receive Active Surveillance, including PSA testing (3 monthly year 1 and 6 monthly years 2 and 3) and MRI scanning (at year 1 and 3). Prostate biopsies will be used for men with changing MRI scans and at year 3.
For further information, please refer to the FINESSE website and our EDI work for Finesse here.
NOVEL trial of nonavalent prophylactic HPV vaccine (GARDASIL® 9) after local conservative treatment for cervical intra-epithelial neoplasia (CIN)
NOVEL is a multi-centre, randomised controlled trial that aims to demonstrate the effectiveness of Nonavalent HPV-vaccine in reducing subsequent persistent HPV infection in women with high-grade CIN, when initiated at the time of local cervical treatment. The study population consists of 1000 females aged between 18 and 55 years with presumed CIN, who were randomly assigned to active (vaccine) or control (no vaccine) arm. Imperial College London sponsor the study, and the CPTU provide statistical support.
For further information, please refer to the NOVEL website.
Cancer Early Diagnosis
The NHS Galleri test study investigating the detection of early-stage cancers through a simple blood test
Developed by GRAIL, the NHS Galleri test, can detect early-stage cancers through a simple blood test. This world-leading programme piloted in collaboration with NHS England. 140,000 asymptomatic participants aged 50 to 77 identified through NHS records, were invited to take part and recruited to have annual blood tests at baseline, year 1 and 2. Anyone with a positive test result is referred for investigation in the NHS. The NHS Galleri teat could help meet the NHS Long Term Plan goal of increasing the proportion of cancers caught early, which can be the key to reducing cancer mortality. Patients whose condition is diagnosed at ‘stage one’ typically have between five to ten times the chance of surviving compared with those found at ‘stage four’.
For further information, please refer to the NHS Galleri website.
The BEST3 trial investigating the Cytosponge test to detect oesophageal cancer earlier
The BEST3 trial has completed recruitment and the trial results have been published. Participating sites have been closed. The trial assessed whether the Cytosponge™ –TFF3 (Trefoil Factor 3) test for patients with reflux symptoms is effective in increasing the detection of Barrett’s oesophagus in primary care compared to the usual clinical pathway. Primary care patients on long-term acid suppressant medication were randomised 1:1 to be invited to receive the Cytosponge™ -TFF3 test in their local GP surgery. If patients tested positive, they received a clinically indicated endoscopy. The Trial started on 1 March 2017 and recruited 110 GP practices and 20 hospitals, with over 13,000 participants enrolled overall and 2,000 tested with the novel device/biomarker.
Cancer Screening
The YORKSURe study investigating early detection of bladder cancer in Yorkshire: Feasibility assessments for implementing a targeted study in populations with high disease specific mortality risk
Yorkshire has some of the lowest survival rates from bladder cancer in Britain. The YORKSURe trial is investigating whether urine self-testing kits and community early detection clinics are an effective way of screening for bladder health problems, which may include bladder cancer. In this trial, home urine self-testing kits are being sent to 3,000 male participants aged between 65 and 80 who have been identified through their GP Practice. Home urine self-testing kits are also being sent to an additional 2000 men and women taking part in Yorkshire Lung Screening Trial to help determine whether urine screening can be embedded within community lung cancer screening programmes. Participants will use the kits to self-test their urine on up to six occasions and those who test positive will be invited to undergo further urine testing (for cancerous cells) and an ultrasound scan at our local screening clinics. Some participants will be randomised to receive a blood test instead of the scan and urine testing. Any participants found to have cancer will be treated at their local hospital. A third cohort will include 500 NHS patients being investigated for bladder cancer in the 2 week wait (2WW) pathway. These participants will also be provided with a urine self-testing kit and their results followed-up. These 3 cohorts will tell us how reliable urine self-testing is for detecting bladder cancer.
For further information, please refer to the YORKSURe website.
FIT for Lynch study, a research exploring the utility and acceptability of faecal immunochemical testing (FIT) as a novel intervention for the improvement of colorectal cancer (CRC) surveillance in individuals with Lynch syndrome
The primary purpose of this pilot study is to better understand if the stool collection kit known as FIT, might be effective in detecting early signs of colorectal cancer in patients with Lynch Syndrome. In addition, preliminary insights into patient attitudes of acceptability for this novel intervention will also be gleaned and analysed through the completion of patient questionnaires as part of said clinical service.
The YouScreen study offered HPV self-sampling in cervical screening to non-attenders within the NHS-cervical screening programme in England.
YouScreen aims to provide the evidence-base that HPV self-sampling can improve cervical screening coverage and to test a new pathway for offering self-sampling to cervical screening non-attenders within the NHS cervical screening programme.
YouScreen has now ended recruitment and trial results will be published in 2023. The study took place in 133 participating GP practices across 5 CCGs in North East and North Central London (Barnet, Tower Hamlets, Newham, Camden, Islington) Women and people with a cervix aged 25-64 years, eligible for cervical screening but at least six months overdue were offered kits by two approaches: via opportunistic offer at their GP Practice and via a direct mailout offer.
The ALOHA study offered self-sampling kits to improve cervical screening coverage among women who are overdue screening
ALOHA is a randomised-controlled pilot trial conducted at 13 GP practices in London within the Hounslow Clinical Commissioning Group (CCG) to randomise 8,420 subjects. GP practices have been randomised 1:1 to offer self-sampling kits opportunistically to women overdue (>6 months) cervical screening when they present (intervention arm) or usual care (control arm). The second randomisation was individual level randomisation of women within each GP practice 2:1:1 to either: Group A Usual care (control). Group B Receiving a letter inviting them to order a kit, or Group C: Receiving a kit in the post. 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.
Smoking Cessation
Smoking cessation for adults experiencing homelessness
Smoking rates among homeless individuals are alarmingly high, with around 60% of this population smoking tobacco compared to the UK average of 14.1%. To address this issue, this cluster randomised controlled trial will investigate whether supplying EC to smokers at homeless centres can help with quitting, and whether it offers cost-effective intervention. The study will evaluate two intervention approaches: providing EC starter packs with either five weekly support telephone calls from an EC helpline; or with just an initial one-off telephone advice. This ground-breaking research will be the first of its kind to explore this important topic. Queen Mary University of London sponsor the study, and the CPTU provides database development and statistical support.
Vapeline aims to study investigate whether public health messages need to focus on encouraging all smokers interested in switching to EC to attend Stop Smoking Services (SSS), or whether simpler options can also be effective for those that cannot or do not wish to engage in intensive programmes.
The trial is testing two approaches that provide EC starter packs: one with five weekly support telephone calls from an EC helpline; and the other, with initial one-off telephone advice. These approaches will be compared with the NHS Smokefree Quit Now online programme that provides e-mails and/or texts daily for 28 days with advice on coping with cravings, using medications and other aids, encouragement to attend local SSS, and motivational messages. A total of 1,170 smokers will be randomly allocated to one of these three study arms to establish how many have stopped smoking 6 and 12 months later. Those who report success will attend for a breath test to confirm that they are no longer smoking. Participants who do not provide this information or do not pass the breath test will be counted as non-abstainers.
Queen Mary University of London sponsor the study, and the CPTU provides statistics and database development support.
The E Cigarette Registry collected long term effects information from e-cigarettes users
The registry was established in response to the CRUK's call to address the evidence gap on e-cigarettes. Current research on vaping and e-cigarettes usually has short follow up periods, resulting in a lack of long-term health data to assess their safety compared to cigarettes and nicotine replacement therapies. The registry provided a free service for researchers to access broad and long-term data for their own participants entered into the registry, with the option of applying for additional information. The registry was coordinated by the CRUK Cancer Prevention Trials Unit at Queen Mary University of London in collaboration with the Queen Mary University London Health and Lifestyle research group.
The pregnant smokers study (PREP) comparing whether behavioural support or electronic cigarettes (EC) works best to help smokers quit.
The PREP trial randomised 1,140 pregnant smokers to either behavioural support (provided by pro-active phone calls and accompanied by nicotine patches), or to the same support accompanied instead by electronic cigarettes (EC). The two study arms will be compared in validated abstinence rates at end of pregnancy and in a number of other outcomes including adverse effects and birth and maternal outcomes. A positive result would provide a new, inexpensive, and practical tool to tackle an important and so far, unresolved problem. The study will recruit pregnant smokers from hospital sites across England and stop-smoking services in Scotland. The trial has now closed to recruitment and the data are being analysed.
