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 of protocol

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 design	Multicentre, randomised, triple blinded, active controlled, parallel group trial.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	High-risk human papillomavirus (HrHPV) in the population research on cervical cancer: a randomised clinical trial
Study acronym	POBASCAM
Study objectives	The 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
Health condition(s) or problem(s) studied	Cervical intraepithelial neoplasia
Intervention	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 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 type	Other
Primary outcome measure	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	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.
Overall study start date	01/01/1999
Completion date	01/09/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	44,102
Key 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
Key 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
Date of first enrolment	01/01/1999
Date of final enrolment	01/09/2007

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"	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 share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan	Not 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.