HPV FOr CervicAL cancer (FOCAL) Trial
The largest randomized trial in Canada assessing primary HPV testing for cervical cancer screening
HPV FOCAL is evaluating the effectiveness and safety of HPV testing compared to the Pap test for cervical cancer prevention. The study recruited over 25,000 BC women, aged 25-65 engaged in cervical cancer screening. Women were randomly assigned to receive the standard of care, cytology (Pap) testing and managed according to provincial guidelines, or they were assigned to primary HPV testing with management determined by the results of HPV testing. This trial is embedded in the BC Cervical Cancer Screening Program, with the ultimate goal of implementing HPV screening provincially in the future.
Ogilvie GS, van Niekerk D, Krajden M, et al. Effect of Screening With Primary Cervical HPV Testing vs. Cytology Testing on High-grade Cervical Intraepithelial Neoplasia at 48 Months: The HPV FOCAL Randomized Clinical Trial. JAMA. 2018;320(1):43–52. doi:10.1001/jama.2018.7464
Ogilvie, G. S., Krajden, M., Niekerk, D. V., Smith, L. W., Cook, D., Ceballos, K., . . . Coldman, A. J. (2016, October 20). HPV for cervical cancer screening (HPV FOCAL): Complete Round 1 results of a randomized trial comparing HPV‐based primary screening to liquid‐based cytology for cervical cancer - Ogilvie - 2017 - International Journal of Cancer - Wiley Online Library. doi:10.1002/ijc.30454
Cook DA, Smith LW, Law J, Mei W, van Niekerk DJ, Ceballos K, Gondara L, Franco EL, Coldman AJ, Ogilvie GS, Jang D, Chernesky M, Krajden M. Aptima HPV Assay versus Hybrid Capture® 2 HPV test for primary cervical cancer screening in the HPV FOCAL trial. J Clin Virol. 2017;87:23-29.
Coldman AJ, Gondara L, Smith LW, van Niekerk D, Ceballos K, Krajden M, Cook D, Quinlan DJ, Lee M, Stuart GC, Peacock S, Martin RE, Gentile L, Franco EL, Ogilvie GS. Disease detection and resource use in the safety and control arms of the HPV FOCAL cervical cancer screening trial. Br J Cancer. 2016;115(12):1487-1494.
Coldman A, van Niekerk D, Smith L, Ogilvie G. Cervical cancer incidence in British Columbia: Predicting effects of changes from Pap to human papillomavirus screening and of changes in screening participation. J Med Screen. 2016; [Epub ahead of print]
Ogilvie GS, Krajden M, van Niekerk D, Smith LW, Cook D, Ceballos K, Lee M, Gentile L, Gondara L, Elwood-Martin R, Peacock S, Stuart G, Franco EL, Coldman AJ. HPV for cervical cancer screening (HPV FOCAL): Complete Round 1 results of a randomized trial comparing HPV-based primary screening to liquid-based cytology for cervical cancer. Int J Cancer. 2017;140(2):440-448.
Smith L, van Niekerk D, Coldman A, Krajden M, Franco EL, Ogilvie G. Recommendations for Implementing Human Papillomavirus-Based Cervical Cancer Screening: Lessons Learned from the HPV FOCAL Trial. J Obstet Gynaecol Can. 2016;38(8):723-6.
Ogilvie GS, Smith LW, van Niekerk D, Khurshed F, Pedersen HN, Taylor D, Thomson K, Greene SB, Babich SM, Franco EL, Coldman AJ. Correlates of women’s intentions to be screened for human papillomavirus for cervical cancer screening with an extended interval. BMC Public Health. 2016;16(1):213.
Cook DA, Mei W, Smith LW, van Niekerk DJ, Ceballos K, Franco EL, Coldman AJ, Ogilvie GS, Krajden M. Comparison of the Roche cobas® 4800 and Digene Hybrid Capture® 2 HPV tests for primary cervical cancer screening in the HPV FOCAL trial. BMC Cancer. 2015;15:968.
Coldman AJ, Phillips N, van Niekerk D, Smith L, Krajden M, Cook D, Quinlan DJ, Ehlen T, Miller D, Stuart GC, Peacock S, Elwood Martin R, Franco EL, Ogilvie G. Projected Impact of HPV and LBC Primary Testing on Rates of Referral for Colposcopy in a Canadian Cervical Cancer Screening Program. J Obstet Gynaecol Can. 2015;37(5):412-20.
Smith LW, Khurshed F, van Niekerk DJ, Krajden M, Greene SB, Hobbs S, Coldman AJ, Franco EL, Ogilvie GS. Women’s intentions to self-collect samples for human papillomavirus testing in an organized cervical cancer screening program. BMC Public Health. 2014;14:1060.
Regier DA, van der Hoek K, Ogilvie G, Smith L, Henwood E, Miller DM, McTaggart-Cowan H, Peacock SJ. Exploring colposcopists’ attitudes towards use of HPV testing as a primary screening tool for cervical cancer in British Columbia. J Obstet Gynaecol Can. 2013 Jul;35(7):657-63.
Ogilvie GS, Smith LW, van Niekerk DJ, Khurshed F, Krajden M, Saraiya M, Goel V, Rimer BK, Greene SB, Hobbs S, Coldman AJ, Franco EL. Women’s intentions to receive cervical cancer screening with primary human papillomavirus testing. Int J Cancer. 2013;133(12):2934-43.
Ogilvie GS, Krajden M, van Niekerk DJ, Martin RE, Ehlen TG, Ceballos K, Smith LW, Kan L, Cook DA, Peacock S, Stuart GC, Franco EL, Coldman AJ. Primary cervical cancer screening with HPV testing compared with liquid-based cytology: results of round 1 of a randomised controlled trial — the HPV FOCAL Study. Br J Cancer. 2012;107(12):1917-24.
Ogilvie GS, van Niekerk DJ, Krajden M, Martin RE, Ehlen TG, Ceballos K, Peacock SJ, Smith LW, Kan L, Cook DA, Mei W, Stuart GC, Franco EL, Coldman AJ. A randomized controlled trial of Human Papillomavirus (HPV) testing for cervical cancer screening: trial design and preliminary results (HPV FOCAL Trial). BMC Cancer. 2010;10:111.