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

Not Applicable

Completed

• Conditions: Cervical intraepithelial neoplasia; Cancer; Cervical cancer

• Registration Number: ISRCTN20781131
• Lead Sponsor: Vrije University Medical Centre (VUMC) (The Netherlands)

Brief Summary

2004 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/15054873 Design, methods and baseline data: 2005 Results article in http://www.ncbi.nlm.nih.gov/pubmed/15900579 Association between higher-grade CIN and HPV type 2007 Other publications in http://www.ncbi.nlm.nih.gov/pubmed/17919718 5-year follow-up 2012 Results article in http://www.ncbi.nlm.nih.gov/pubmed/22177579 Final results 2018 Other publications in https://www.ncbi.nlm.nih.gov/pubmed/29663363 Post hoc analysis of 14-year follow-up data 2022 Other publications in https://pubmed.ncbi.nlm.nih.gov/36306283/ Association between cervical precancer risk at 14 years and previous screening results (added 31/10/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-20
• Study Completion: 2007-09-01
• Last Update Posted: 14 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 44102

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.