The SCRIPT trial: study protocol for a randomised controlled trial of a polygenic risk score to tailor colorectal cancer screening in primary care.

Autor: Saya S; Primary Care Cancer Research Group, Department of General Practice, Centre for Cancer Research, The University of Melbourne, Victorian Comprehensive Cancer Centre, Level 10, 305 Grattan Street, Melbourne, Victoria, 3000, Australia. sibel.saya@unimelb.edu.au.; Centre for Cancer Research, University of Melbourne, Melbourne, Australia. sibel.saya@unimelb.edu.au., Boyd L; Primary Care Cancer Research Group, Department of General Practice, Centre for Cancer Research, The University of Melbourne, Victorian Comprehensive Cancer Centre, Level 10, 305 Grattan Street, Melbourne, Victoria, 3000, Australia.; Centre for Cancer Research, University of Melbourne, Melbourne, Australia., Chondros P; Primary Care Cancer Research Group, Department of General Practice, Centre for Cancer Research, The University of Melbourne, Victorian Comprehensive Cancer Centre, Level 10, 305 Grattan Street, Melbourne, Victoria, 3000, Australia., McNamara M; Primary Care Cancer Research Group, Department of General Practice, Centre for Cancer Research, The University of Melbourne, Victorian Comprehensive Cancer Centre, Level 10, 305 Grattan Street, Melbourne, Victoria, 3000, Australia.; Centre for Cancer Research, University of Melbourne, Melbourne, Australia., King M; Primary Care Cancer Research Group, Department of General Practice, Centre for Cancer Research, The University of Melbourne, Victorian Comprehensive Cancer Centre, Level 10, 305 Grattan Street, Melbourne, Victoria, 3000, Australia.; Centre for Cancer Research, University of Melbourne, Melbourne, Australia., Milton S; Primary Care Cancer Research Group, Department of General Practice, Centre for Cancer Research, The University of Melbourne, Victorian Comprehensive Cancer Centre, Level 10, 305 Grattan Street, Melbourne, Victoria, 3000, Australia.; Centre for Cancer Research, University of Melbourne, Melbourne, Australia., Lourenco RA; Centre for Health Economics Research and Evaluation, University of Technology Sydney, Sydney, Australia., Clark M; IPN Medical Centres, Camberwell, Australia., Fishman G; Consumer Advisory Group, Primary Care Collaborative Cancer Clinical Trials Group, Carlton, Australia., Marker J; Consumer Advisory Group, Primary Care Collaborative Cancer Clinical Trials Group, Carlton, Australia., Ostroff C; Centre for Workplace Excellence, University of South Australia, Adelaide, Australia., Allman R; Genetic Technologies/Phenogen Sciences, Fitzroy, Australia.; Centre for Epidemiology and Biostatistics, The University of Melbourne, Melbourne, Australia., Walter FM; Primary Care Cancer Research Group, Department of General Practice, Centre for Cancer Research, The University of Melbourne, Victorian Comprehensive Cancer Centre, Level 10, 305 Grattan Street, Melbourne, Victoria, 3000, Australia.; Wolfson Institute of Population Health, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK., Buchanan D; Centre for Cancer Research, University of Melbourne, Melbourne, Australia.; Centre for Epidemiology and Biostatistics, The University of Melbourne, Melbourne, Australia.; Department of Clinical Pathology, University of Melbourne, Melbourne, Australia., Winship I; Department of Medicine, Melbourne Medical School, University of Melbourne, Melbourne, Australia.; Genetic Medicine, Royal Melbourne Hospital, Melbourne, Australia., McIntosh J; Primary Care Cancer Research Group, Department of General Practice, Centre for Cancer Research, The University of Melbourne, Victorian Comprehensive Cancer Centre, Level 10, 305 Grattan Street, Melbourne, Victoria, 3000, Australia.; HumaniSE Lab, Department of Software Systems and Cybersecurity, Monash University, Clayton, Australia., Macrae F; Department of Medicine, Melbourne Medical School, University of Melbourne, Melbourne, Australia.; Colorectal Medicine and Genetics, The Royal Melbourne Hospital, Melbourne, Australia., Jenkins M; Centre for Cancer Research, University of Melbourne, Melbourne, Australia.; Centre for Epidemiology and Biostatistics, The University of Melbourne, Melbourne, Australia., Emery J; Primary Care Cancer Research Group, Department of General Practice, Centre for Cancer Research, The University of Melbourne, Victorian Comprehensive Cancer Centre, Level 10, 305 Grattan Street, Melbourne, Victoria, 3000, Australia.; Centre for Cancer Research, University of Melbourne, Melbourne, Australia.
Jazyk: angličtina
Zdroj: Trials [Trials] 2022 Sep 27; Vol. 23 (1), pp. 810. Date of Electronic Publication: 2022 Sep 27.
DOI: 10.1186/s13063-022-06734-7
Abstrakt: Background: Polygenic risk scores (PRSs) can predict the risk of colorectal cancer (CRC) and target screening more precisely than current guidelines using age and family history alone. Primary care, as a far-reaching point of healthcare and routine provider of cancer screening and risk information, may be an ideal location for their widespread implementation.
Methods: This trial aims to determine whether the SCRIPT intervention results in more risk-appropriate CRC screening after 12 months in individuals attending general practice, compared with standard cancer risk reduction information. The SCRIPT intervention consists of a CRC PRS, tailored risk-specific screening recommendations and a risk report for participants and their GP, delivered in general practice. Patients aged between 45 and 70 inclusive, attending their GP, will be approached for participation. For those over 50, only those overdue for CRC screening will be eligible to participate. Two hundred and seventy-four participants will be randomised to the intervention or control arms, stratified by general practice, using a computer-generated allocation sequence. The primary outcome is risk-appropriate CRC screening after 12 months. For those in the intervention arm, risk-appropriate screening is defined using PRS-derived risk; for those in the control arm, it is defined using family history and national screening guidelines. Timing, type and results of the previous screening are considered in both arms. Objective health service data will capture screening behaviour. Secondary outcomes include cancer-specific worry, risk perception, predictors of CRC screening behaviour, screening intentions and health service use at 1, 6 and 12 months post-intervention delivery.
Discussion: This trial aims to determine whether a PRS-derived personalised CRC risk estimate delivered in primary care increases risk-appropriate CRC screening. A future population risk-stratified CRC screening programme could incorporate risk assessment within primary care while encouraging adherence to targeted screening recommendations.
Trial Registration: Australian and New Zealand Clinical Trial Registry ACTRN12621000092897p. Registered on 1 February 2021.
(© 2022. The Author(s).)
Databáze: MEDLINE
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