Title: Cancer Research UK Prevention Trials Unit (CPTU) core funding
Funder: Cancer Research UK

Abstract: Background: This application is for the renewal of the core funding of the Cancer Research UK Cancer Prevention Trials Unit (CPTU): a CTU specialising in cancer prevention, screening and early detection. Aims: To facilitate high-quality clinical trials and other well-designed studies to produce the evidence base needed to advance: •Cancer prevention via medicinal treatments (with fewer side-effects) and behavioural interventions; •Prevention via detection of pre-cancerous lesions; •Cancer early diagnosis via screening; •Smoking quit rates. Methods: Our portfolio of secondary (hospital) and primary (community) care trials will include: •Medicinal prevention (of breast and prostate cancer in particular) often using drug re-purposing; •Behavioural interventions in cancer prevention (exercise) and screening (to improve uptake); •Diagnostic/screening devices (such as the Cytosponge for Barrett’s oesophagus); •Smoking cessation (psychological and pharmacological interventions including e-cigarettes); •Pragmatic trials of screening interventions (e.g. cervical self-sampling; and timed second appointments); •Long-term follow-up of participants from successful RCTs (of breast cancer prevention and treatment in particular); •Bio-specimen collections for biomarker discovery and validation. We will design, conduct, analyse and publish phase III trials as well as early-phase trials of prophylactic agents. We will use biomarkers to guide risk-adapted screening and prevention strategies, to provide more rapid indicators of response to treatment, and to maximise what can be learnt from trial participants. Current operational capabilities facilitate the development of recruitment strategies and electronic data capture solutions tailored to the needs of each trial. We will provide patients with the opportunity to critically appraise and contribute to our research processes. We are active in methodological research and often implement novel designs (and analyses). We will: •Continue to pioneer the use of electronic records for extended follow-up; •Study novel paradigms to enable smaller trials involving multiple treatment arms; •Continue to derive and implement novel methods to preserve randomised comparisons in the presence of non-compliance or opportunistic cross-over. •Promote use of electronic patient records, and computer applications for recruitment and management of participants. •Use aggregated data in cluster randomised controlled trials lacking individual level consent. How the results of this research will be used: The infrastructure will be used to encourage, design and facilitate practice-changing trials in cancer prevention, early diagnosis and screening. All trials will be published in high-impact journals, accompanied by a press-release. All results will be disseminated in partnership with our patient advisory groups. Where relevant evidence will be presented to NICE and similar organisations.

Lay abstract: Background: This application is for the renewal of the core funding of the Cancer Research UK Cancer Prevention Trials Unit (CPTU): a CTU specialising in cancer prevention, screening and early detection. Aims: To facilitate high-quality clinical trials and other well-designed studies to produce the evidence base needed to advance: •Cancer prevention via medicinal treatments (with fewer side-effects) and behavioural interventions; •Prevention via detection of pre-cancerous lesions; •Cancer early diagnosis via screening; •Smoking quit rates. Methods: Our portfolio of secondary (hospital) and primary (community) care trials will include: •Medicinal prevention (of breast and prostate cancer in particular) often using drug re-purposing; •Behavioural interventions in cancer prevention (exercise) and screening (to improve uptake); •Diagnostic/screening devices (such as the Cytosponge for Barrett’s oesophagus); •Smoking cessation (psychological and pharmacological interventions including e-cigarettes); •Pragmatic trials of screening interventions (e.g. cervical self-sampling; and timed second appointments); •Long-term follow-up of participants from successful RCTs (of breast cancer prevention and treatment in particular); •Bio-specimen collections for biomarker discovery and validation. We will design, conduct, analyse and publish phase III trials as well as early-phase trials of prophylactic agents. We will use biomarkers to guide risk-adapted screening and prevention strategies, to provide more rapid indicators of response to treatment, and to maximise what can be learnt from trial participants. Current operational capabilities facilitate the development of recruitment strategies and electronic data capture solutions tailored to the needs of each trial. We will provide patients with the opportunity to critically appraise and contribute to our research processes. We are active in methodological research and often implement novel designs (and analyses). We will: •Continue to pioneer the use of electronic records for extended follow-up; •Study novel paradigms to enable smaller trials involving multiple treatment arms; •Continue to derive and implement novel methods to preserve randomised comparisons in the presence of non-compliance or opportunistic cross-over. •Promote use of electronic patient records, and computer applications for recruitment and management of participants. •Use aggregated data in cluster randomised controlled trials lacking individual level consent. How the results of this research will be used: The infrastructure will be used to encourage, design and facilitate practice-changing trials in cancer prevention, early diagnosis and screening. All trials will be published in high-impact journals, accompanied by a press-release. All results will be disseminated in partnership with our patient advisory groups. Where relevant evidence will be presented to NICE and similar organisations.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING;3.3 NUTRITION AND CHEMOPREVENTION;3.5 RESOURCES AND INFRASTRUCTURE (PREVENTION);4.4 POPULATION SCREENING
Health categories: CANCER AND NEOPLASMS