COMPLETED TRIALS

Cancer early diagnosis

BEST3

BEST3:  Randomised controlled trial comparing the Cytosponge-TFF3 test with usual care to facilitate the diagnosis of oesophageal pre-cancer in primary care 


BEST3 investigated whether offering a sponge on a string to patients on long term acid suppressants would increase the increase the number of patients diagnosed with BO compared with standard management. A multicentre, pragmatic, randomised controlled trial was delivered across general practice clinics in England. 109 GPs in England took part. Overall, 13,222 patients participated and over half were invited to have a Cytosponge-TFF3 test.


Results, published in The Lancet, found 140 cases of Barrett’s were diagnosed in the Cytosponge group compared with usual care i.e. the odds of detecting Barret’s was ten times higher in the Cytosponge group. Additionally, that Cytosponge-TFF3 testing could potentially lead to the diagnosis of treatable dysplasia and early cancer.


BEST4 is currently underway - see current trials under 'Trial portfolio' for more info.


Further info: ISRCTN registry.

Cancer screening

YouScreen

YouScreen:  A pragmatic implementation feasibility clinical trial of offering HPV self-sampling to cervical screening non-attenders within the NHS cervical screening programme in England 


YouScreen 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. This 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. 

The UK National Screening Committee (UKNSC) is now consulting on offering HPV self-sampling to under-screened people in the cervical screening programme.


See research updates under 'About us' for more info.


Further info: ISRCTN registry.

ALOHA

ALOHA: Self-sampling for HPV testing in cervical screening nonattenders in London


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: 

• Group A (Control): Usual care 

• Group B (Intervention): A letter inviting them to order a self-sampling kit 

• Group C (Intervention): A kit sent directly by post. 


The primary analysis showed 5.6% of women in the intervention arm returned a self-sample within 6 months, compared to 1.8% in the control arm. The results showed that the uptake of self-sampling among women was by far the highest among women who were opportunistically offered kits in primary care, and that an opt-in approach Is likely to have limited success. Compliance to follow up amongst self-sample HPV positive was relatively high. 


Further info: ISRCTN registry.

Smoking cessation

E-Cigarette Registry

E-Cigarette Registry:  A long-term health data repository of people who have quit smoking with and without using e-cigarettes


EC Registry attempted to deliver a national registry of participants that have been involved in EC trialS and stopped smoking with and without switching to vaping, with a view to collecting long term follow up data from electronic health record registries to deliver large-scale, cost-effective, long term follow up in key conditions of interest for smoking-related diseases.


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 project drew to a close in early 2023 following COVID and recruitment related challenges. 


For further info, please see the ISRCTN registry.

PREP

PREP:  Helping Pregnant Smokers Quit: A Multi-Centre RCT of Electronic Cigarette and Nicotine Patches


PREP (Pregnant Smokers Study) trial compared these e-cigarettes and nicotine patches for smoking cessation during pregnancy. A total of 1,140 pregnant smokers were randomized to receive behavioral support (delivered via proactive phone calls) along with either nicotine patches or electronic cigarettes (EC).


Results, published in Nature, indicated that validated abstinence rates at the end of pregnancy did not differ significantly between the two groups. However, some participants in the nicotine patch group also used e-cigarettes during the trial. A pre-specified sensitivity analysis, which excluded abstinent participants who used non-allocated products, revealed that e-cigarettes were more effective than patches in promoting smoking cessation.


The safety profiles of the two interventions were found to be similar. Notably, low birthweight was less frequent in the e-cigarette arm. These findings suggest that e-cigarettes may help pregnant women quit smoking, with a safety profile comparable to nicotine patches.


For further info, please see the ISRCTN registry.