High-risk human papillomavirus (HrHPV) in the population research on cervical cancer

Conditions

Cervical intraepithelial neoplasia Cancer Cervical cancer

Federica Inturrisi, Lawrence Rozendaal, Nienke J. Veldhuijzen, Daniëlle A.M. Heideman, Chris J.L.M. Meijer et al. (6 authors)

PLoS Medicine2022-10-2820 citations

10.1371/journal.pmed.1004115

Cervical cancer risk in HPV‐positive women after a negative <i>FAM19A4/mir124‐2</i> methylation test: A post hoc analysis in the POBASCAM trial with 14 year follow‐up

Lise M.A. De Strooper, Johannes Berkhof, Renske D.M. Steenbergen, Birgit I. Lissenberg‐Witte, Peter J.F. Snijders et al. (7 authors)

International Journal of Cancer2018-04-17111 citations

10.1002/ijc.31539

Safety of extending screening intervals beyond five years in cervical screening programmes with testing for high risk human papillomavirus: 14 year follow-up of population based randomised cohort in the Netherlands

Maaike G. Dijkstra, Marjolein van Zummeren, Lawrence Rozendaal, Folkert J. van Kemenade, Theo J.M. Helmerhorst et al. (8 authors)

BMJ2016-10-04116 citations

10.1136/bmj.i4924

Human papillomavirus testing for the detection of high-grade cervical intraepithelial neoplasia and cancer: final results of the POBASCAM randomised controlled trial.

Rijkaart DC, Berkhof J, Rozendaal L, van Kemenade FJ, Bulkmans NW, Heideman DA, Kenter GG, Cuzick J, Snijders PJ, Meijer CJ.

2011-12-14357 citations

10.1016/s1470-2045(11)70296-0

Human papillomavirus DNA testing for the detection of cervical intraepithelial neoplasia grade 3 and cancer: 5-year follow-up of a randomised controlled implementation trial.

Bulkmans NW, Berkhof J, Rozendaal L, van Kemenade FJ, Boeke AJ, Bulk S, Voorhorst FJ, Verheijen RH, van Groningen K, Boon ME, Ruitinga W, van Ballegooijen M, Snijders PJ, Meijer CJ.

2007-10-04434 citations

10.1016/s0140-6736(07)61450-0

Interventions

In the POBASCAM trial, the addition of a high-risk human papillomavirus (hrHPV) test to the regular cervical screening programme to improve detection of precursor lesions of cervical cancer is evaluat

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Women invited for the cervical cancer screening program (ages 30 - 60 years) 2. Residing in either the region covered by district health authority Amstelland-de Meerlanden and Zuid-Kennemerland

Exclusion criteria

Exclusion criteria: 1. Not called for screening, ie ages under 30 years, or over 60 years 2. Follow-up of previous non-normal cytology within the current screening round of the program, i.e., abnormal cytology or CIN lesions less than two years before inclusion 3. Status after extirpation of the uterus or amputation of the portio

Design outcomes

Primary

Measure	Time frame
The primary outcome measure of POBASCAM trial is the occurrence of histologically confirmed CIN3 lesions or (micro-) invasive carcinoma of the cervix found during the time span from intake up to and including the next screening round, i.e., in five years. Since women with normal cytology at the next screening round will not be referred for colposcopically-directed biopsies and therefore will not have a histological endpoint, it will be assumed that no precursor lesions of cervical cancer are present. This policy complies with regular cervical screening in The Netherlands.	—

Measure

Time frame

The primary outcome measure of POBASCAM trial is the occurrence of histologically confirmed CIN3 lesions or (micro-) invasive carcinoma of the cervix found during the time span from intake up to and including the next screening round, i.e., in five years. Since women with normal cytology at the next screening round will not be referred for colposcopically-directed biopsies and therefore will not have a histological endpoint, it will be assumed that no precursor lesions of cervical cancer are present. This policy complies with regular cervical screening in The Netherlands.

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Secondary

Measure	Time frame
As a secondary outcome measure, histologically confirmed cervical intraepithelial neoplasia grade 2 will also be investigated, since current guidelines recommend ablative treatment for these lesions as well. Other secondary parameters obtained include progression and regression of cytology diagnoses, clearance and acquisition of hrHPV infections and the number of referrals for colposcopically-directed biopsies.	—

Measure

Time frame

As a secondary outcome measure, histologically confirmed cervical intraepithelial neoplasia grade 2 will also be investigated, since current guidelines recommend ablative treatment for these lesions as well. Other secondary parameters obtained include progression and regression of cytology diagnoses, clearance and acquisition of hrHPV infections and the number of referrals for colposcopically-directed biopsies.

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Countries

Netherlands

Outcome results

None listed