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

ISRCTN ISRCTN20781131
DOI https://doi.org/10.1186/ISRCTN20781131
Secondary identifying numbers 1998/04WBO; NTR218
Submission date
20/12/2005
Registration date
20/12/2005
Last edited
31/10/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr NWJ Bulkmans
Scientific

VU University Medical Center
Department of Pathology
De Boelelaan 1117
Amsterdam
1081 VH
Netherlands

Phone +31 (0)20 4440102
Email n.bulkmans@vumc.nl

Study information

Study designMulticentre, randomised, triple blinded, active controlled, parallel group trial.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleHigh-risk human papillomavirus (HrHPV) in the population research on cervical cancer: a randomised clinical trial
Study acronymPOBASCAM
Study hypothesisThe main aims of the POBASCAM trial are to find out whether the efficacy and cost-effectiveness of the cervical screening programme can be improved by increasing the screening interval for women with normal cytology and a negative high-risk human papillomavirus (hrHPV) test, and by referring women with mild cytological abnormalities and a negative hrHPV test back to the next screening round, without increasing the risk of missing cervical intraepithelial neoplasia 3 (CIN3) lesions or cervical cancer.
Ethics approval(s)Ethics approval received from the local medical ethics committee
ConditionCervical intraepithelial neoplasia
InterventionIn 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 evaluated in a randomised trial design.

During the trial, participants will receive either the regular test results and regular repeat and referral recommendations (control group, hrHPV test results blinded to participants, treating clinicians and study personnel) or participants will receive modified repeat and referral recommendations based on the presence or absence of hrHPV in the cervical smear (intervention group, hrHPV test results disclosed).
Intervention typeOther
Primary outcome measureThe 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 measuresAs 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.
Overall study start date01/01/1999
Overall study end date01/09/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants44,102
Participant inclusion criteria1. 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
Participant exclusion criteria1. 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
Recruitment start date01/01/1999
Recruitment end date01/09/2007

Locations

Countries of recruitment

  • Netherlands

Study participating centre

VU University Medical Center,
Amsterdam
1081 VH
Netherlands

Sponsor information

Vrije University Medical Centre (VUMC) (The Netherlands)
University/education

Department of Pathology
PO Box 7057
Amsterdam
1007 MB
Netherlands

ROR logo "ROR" https://ror.org/00q6h8f30

Funders

Funder type

Research organisation

The Netherlands Organization for Health Research and Development (ZonMw) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications Design, methods and baseline data: 20/05/2004 Yes No
Results article Association between higher-grade CIN and HPV type 01/11/2005 Yes No
Other publications 5-year follow-up 24/11/2007 Yes No
Results article Final results 01/01/2012 Yes No
Other publications Post hoc analysis of 14-year follow-up data 15/09/2018 Yes No
Other publications Association between cervical precancer risk at 14 years and previous screening results 28/10/2022 31/10/2022 Yes No

Editorial Notes

31/10/2022: Publication reference added.
05/02/2019: Publication reference added.
20/09/2017: internal review.