High-risk human papillomavirus (HrHPV) in the population research on cervical cancer
ISRCTN | ISRCTN20781131 |
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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
Scientific
VU University Medical Center
Department of Pathology
De Boelelaan 1117
Amsterdam
1081 VH
Netherlands
Phone | +31 (0)20 4440102 |
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n.bulkmans@vumc.nl |
Study information
Study design | Multicentre, randomised, triple blinded, active controlled, parallel group trial. |
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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 hypothesis | 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 |
Condition | 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 |
Overall study end date | 01/09/2007 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Female |
Target number of participants | 44,102 |
Participant 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 |
Participant 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 |
Recruitment start date | 01/01/1999 |
Recruitment end date | 01/09/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU University Medical Center,
Amsterdam
1081 VH
Netherlands
1081 VH
Netherlands
Sponsor information
Vrije University Medical Centre (VUMC) (The Netherlands)
University/education
University/education
Department of Pathology
PO Box 7057
Amsterdam
1007 MB
Netherlands
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 | |
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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? |
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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.