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High-risk human papillomavirus (HrHPV) in the population research on cervical cancer
DOI 10.1186/ISRCTN20781131
ClinicalTrials.gov identifier
EudraCT number
Public title High-risk human papillomavirus (HrHPV) in the population research on cervical cancer
Scientific title
Serial number at source 1998/04WBO; NTR218
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.
Lay summary Not provided at time of registration
Ethics approval Ethics approval received from the local medical ethics committee
Study design Multicentre, randomised, triple blinded, active controlled, parallel group trial.
Countries of recruitment Netherlands
Disease/condition/study domain Cervical intraepithelial neoplasia
Participants - 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
Participants - 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
Anticipated start date 01/01/1999
Anticipated end date 01/09/2007
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 44,102
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 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).
Primary outcome measure(s) 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 measure(s) 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.
Sources of funding The Netherlands Organization for Health Research and Development (ZonMw) (The Netherlands)
Trial website
Publications 1. Design, methods and baseline data: http://www.ncbi.nlm.nih.gov/pubmed/15054873
2. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15900579
3. 2007 five-year follow up in http://www.ncbi.nlm.nih.gov/pubmed/17919718
4.. 2012 final results in http://www.ncbi.nlm.nih.gov/pubmed/22177579
Contact name Dr  NWJ  Bulkmans
  Address VU University Medical Center,
Department of Pathology,
De Boelelaan 1117
  City/town Amsterdam
  Zip/Postcode 1081 VH
  Country Netherlands
  Tel +31 (0)20 4440102
  Email n.bulkmans@vumc.nl
Sponsor Vrije University Medical Centre (VUMC) (The Netherlands)
  Address Department of Pathology
PO Box 7057
  City/town Amsterdam
  Zip/Postcode 1007 MB
  Country Netherlands
Date applied 20/12/2005
Last edited 23/02/2012
Date ISRCTN assigned 20/12/2005
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