YORKSURE - Bladder Cancer Screening

Yorkshire has some of the lowest survival rates from bladder cancer in Britain. Improvements in survival could be delivered through earlier diagnosis by screening individuals at high-risk of dying from this cancer. The Yorksure studies will investigate the best method to find and test persons for bladder cancer, and how many cancers may exist: 1) Self-testing for bladder cancer: 2,000 screen-engaged participants attending the Yorkshire Lung Screening Trial will test their urine for blood. Those positive will undergo further urine testing (for cancerous cells) and an ultrasound scan. 2) 3,000 male participants (65-80 years) will be sent home urine dipstick tests for them to self-test their urine up to six occasions. Men with blood in their urine will be invited to attend our local screening clinics for urine cytology and ultrasound. Those with cancer will be treated at their local hospital. 3) 500 NHS patients being investigated for bladder cancer in the 2 week wait (2WW) pathway will also be followed-up. These 3 cohorts will tell us how reliable urine self-testing is for detecting bladder cancer.

FINESSE - Prostate cancer progression prevention

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.

Vapeline – Smoking cessation

The trial will 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 those that cannot or do not wish to engage in intensive programmes can benefit from simpler options. The research will test two approaches that provide EC starter packs: either with five weekly support telephone calls from an EC helpline; or just with initial one-off telephone advice. This 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 allocated to one of these three study arms at random and we will 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.

YouScreen – Cervical cancer screening

The YouScreen study aims to investigate self-sampling for HPV testing in women aged 25-64 years who are eligible for cervical screening but are at least six months overdue according to GP records, to estimate the uptake and potential increase in coverage with offering self-sampling. Patients are being recruited from GP practices in five CCGs in North East and North Central London (Barnet, Tower Hamlets, Newham, Camden, Islington) to provide the evidence-base for the implementation of offering self-sampling to cervical screening non-attenders. Self-sampling kits are being distributed using two approaches: direct mail out and opportunistic offering at GP appointments. The study aims to obtain results for 10,000 participants following 40,000 invitations being sent out.

PREP Trial – Smoking cessation

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.

ALOHA

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.

BEST3 – Oesophageal cancer early detection

The BEST3 trial has completed recruitment and the trial results have been published. Participating sites are in the process of being closed and various dissemination events are being organised. 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.

Results from the BEST3 trial: How effective is the Cytosponge test in a primary care setting?

Smoking Relapse Prevention Trial

The Smoking Relapse Prevention (RP) Trial is a 4 arm Randomised Controlled Trial to determine if providing additional strategies designed to cope with temptations to smoke (behavioural support and/or access to smoking replacement [SR]), including electronic cigarettes (EC), can reduce relapse rates in short-term ex-smokers over a 12 month follow-up period. The primary outcome measure of abstinence is measured by a follow up survey at three, six and 12 month post quit date, and biochemically validated with a saliva sample. The trial was run in the UK and Australia,and is now closed to recruitment. Trial results will be published shortly.

E-Cigarette Registry

The E-Cigarette Registry is a direct response to the CRUK call to address the evidence gap on e-cigarettes. In vaping and e-cigarette research the follow-up periods tend to be short, leading to a lack in long-term health data available to assess their safety alongside cigarettes and nicotine replacement therapies. We want to provide a free service so researchers can access broad and long-term data for their own participants entered into the registry, with the option of applying for additional information. It is coordinated by the Cancer Research UK & King's College London Cancer Prevention Trials Unit in collaboration with the Queen Mary University London Health and Lifestyle research group.

NOVEL

NOVELTrial: Nonavalent prophylactic HPV vaccine (GARDASIL9) after local conservative treatment for cervical intra-epithelial neoplasia (CIN).This is a multi-centre, randomised controlled trial to demonstrate that Nonavalent HPV-vaccine, when initiated at the time of local cervical treatment, will reduce subsequent persistent HPV infection in women with high-grade CIN. The study population will be 1000 females aged between 18 and 55 years with presumed CIN, randomised to active (vaccine) or control (no vaccine) arm and recruited over a 12 month period. Imperial College London will sponsor the study, and CPTU will be involved by providing statistical support for this study.