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Human Papillomavirus Testing and Liquid-Based Cytology: Results at Recruitment From the New Technologies for Cervical Cancer Randomized Controlled Trial
Abstract
BACKGROUND: Although testing for human papillomavirus (HPV) has higher sensitivity and lower specificity than cytology alone for detecting cervical intraepithelial neoplasia (CIN), studies comparing conventional and liquid-based cytology have had conflicting results. METHODS: In the first phase of a two-phase multicenter randomized controlled trial, women aged 35-60 years in the conventional arm (n = 16,658) were screened using conventional cytology, and women in the experimental arm (n = 16,706) had liquid-based cytology and were tested for high-risk HPV types using the Hybrid Capture 2 assay. Women in the conventional arm were referred to colposcopy with atypical cells of undetermined significance (ASCUS) or higher and those in the experimental arm were referred with ASCUS or higher cytology or with a positive (> or = 1 pg/mL) HPV test. Sensitivity and positive predictive value (PPV) for detection of cervical intraepithelial neoplasia grade 2 or higher (CIN2+) were calculated. RESULTS: The screening methods and referral criterion applied in the experimental arm had higher sensitivity than that in the conventional arm (relative sensitivity = 1.47; 95% confidence interval [CI] = 1.03 to 2.09) but a lower PPV (relative PPV = 0.40; 95% CI = 0.23 to 0.66). With HPV testing alone at > or = 1 pg/mL and at > or = 2 pg/mL, the gain in sensitivity compared with the conventional arm remained similar (relative sensitivity = 1.43, 95% CI = 1.00 to 2.04 and relative sensitivity = 1.41, 95% CI = 0.98 to 2.01, respectively) but PPV progressively improved (relative PPV = 0.58, 95% CI = 0.33 to 0.98 and relative PPV = 0.75, 95% CI = 0.45 and 1.27, respectively). Referral based on liquid-based cytology alone did not increase sensitivity compared with conventional cytology (relative sensitivity = 1.06; 95% CI = 0.72 to 1.55) but reduced PPV (relative PPV = 0.57; 95% CI = 0.39 to 0.82). CONCLUSIONS: HPV testing alone was more sensitive than conventional cytology among women 35-60 years old. Adding liquid-based cytology improved sensitivity only marginally but increased false-positives. HPV testing using Hybrid Capture 2 with a 2 pg/mL cutoff may be more appropriate than a 1 pg/mL cutoff for primary cervical cancer screening.
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Management of women who test positive for high-risk types of human papillomavirus: the HART study
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Ronco, G., Dillner, J., Elfström, K. M., Tunesi, S., Snijders, P. J. F., Arbyn, M., Kitchener, H., Segnan, N., Gilham, C., Giorgi-Rossi, P., et al. (2014) · The Lancet · doi:10.1016/s0140-6736(13)62218-7 · Cited by 1,810
Self-citationScreening for Cervical Cancer: US Preventive Services Task Force Recommendation Statement
US Preventive Services Task Force, Curry, S. J., Krist, A. H., Owens, D. K., Barry, M. J., Caughey, A. B., Davidson, K. W., Doubeni, C. A., Epling, J. W., Kemper, A. R., et al. (2018) · JAMA · doi:10.1001/jama.2018.10897 · Cited by 1,409
Ronco, G., Giorgi-Rossi, P., Carozzi, F., Confortini, M., Palma, P. D., Del Mistro, A., Ghiringhello, B., Girlando, S., Gillio-Tos, A., De Marco, L., et al. (2010) · The Lancet Oncology · doi:10.1016/s1470-2045(09)70360-2 · Cited by 936
Self-citationEvidence Regarding Human Papillomavirus Testing in Secondary Prevention of Cervical Cancer
Arbyn, M., Ronco, G., Anttila, A., Meijer, C. J. L. M., Poljak, M., Ogilvie, G., Koliopoulos, G., Naucler, P., Sankaranarayanan, R., & Peto, J. (2012) · Vaccine · doi:10.1016/j.vaccine.2012.06.095 · Cited by 897
Self-citationMeijer, C. J. L. M., Berkhof, J., Castle, P. E., Hesselink, A. T., Franco, E. L., Ronco, G., Arbyn, M., Bosch, F. X., Cuzick, J., Dillner, J., et al. (2009) · International Journal of Cancer · doi:10.1002/ijc.24010 · Cited by 692
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Metadata
- Authors
- Ronco, G., Segnan, N., Giorgi-Rossi, P., Zappa, M., Casadei, G. P., Carozzi, F., Palma, P. D., Del Mistro, A., Folicaldi, S., Gillio-Tos, A., Nardo, G., Naldoni, C., Schincaglia, P., Zorzi, M., Confortini, M., & Cuzick, J.
- Venue
- JNCI: Journal of the National Cancer Institute
- Publisher
- Oxford University Press (OUP)
- Published
- 2006-06-07
- Volume
- 98
- Issue
- 11
- Pages
- 765-774
- ISSN
- 0027-8874 (ISSN-L)
- 1460-2105
- OpenAlex
- W2126725601
- Cited by
- 313
- References
- 29
- FWCI
- 24.35
- Type
- journal article
- Language
- en
- Open access
- closed
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- Ronco, G., Segnan, N., Giorgi-Rossi, P., Zappa, M., Casadei, G. P., Carozzi, F., Palma, P. D., Del Mistro, A., Folicaldi, S., Gillio-Tos, A., Nardo, G., Naldoni, C., Schincaglia, P., Zorzi, M., Confortini, M., & Cuzick, J. (2006). Human Papillomavirus Testing and Liquid-Based Cytology: Results at Recruitment From the New Technologies for Cervical Cancer Randomized Controlled Trial. JNCI: Journal of the National Cancer Institute. https://doi.org/10.1093/jnci/djj209
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