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PRotection by Offering Human papillomavirus Testing on sElf-sampled Cervicovaginal specimens Trial
ISRCTN ISRCTN45527158
DOI 10.1186/ISRCTN45527158
ClinicalTrials.gov identifier
EudraCT number
Public title PRotection by Offering Human papillomavirus Testing on sElf-sampled Cervicovaginal specimens Trial
Scientific title
Acronym PROHTECT
Serial number at source 2006/01WBO
Study hypothesis The main aims of the PROHTECT trial are to find out whether the compliance rate of the cervical screening programme can be improved by offering a self-sampling method for collecting cervicovaginal cell material at home for Human PapillomaVirus (HPV) testing, and consequently the (cost)-effectiveness of screening will be enhanced due to increased detection of high grade Cervical Intraepithelial Neoplasia (CIN) lesions or worse (more than or equal to CIN grade two to three)?
Lay summary
Ethics approval The PROHTECT trial has been approved by the Dutch Ministry of Health, Welfare and Sports (reference number: 2006/01WBO), date of approval: 11th May 2006. In addition, the Ethics Board of the VU University Medical Center has approved the study.
Study design Randomised, controlled, parallel group trial
Countries of recruitment Netherlands
Disease/condition/study domain Cervical Intraepithelial Neoplasia (CIN), cervix cancer, uterus
Participants - inclusion criteria 1. Women invited for the cervical cancer screening program (ages 30 to 60 years), but who are not responding to their invitation as well as their recall (three months after)
2. Residing in the region covered by district health authorities of North Holland and Flevoland (in the Netherlands)
Participants - exclusion criteria 1. Not called for screening, i.e., ages under 30 years, or over 60 years
2. Actively responded to the invitation or first recall of the cervical screening program by undergoing a cervical smear at the general practitioner
3. Living outside the region covered by district health authorities of North Holland and Flevoland
4. Under follow-up by gynaecologist for previous non-normal cytology, i.e., abnormal cytology and/or CIN three lesion or worse less than two years before inclusion
5. Current pregnancy
6. Status after extirpation of the uterus or amputation of the portio
Anticipated start date 01/10/2006
Anticipated end date 01/03/2009
Status of trial Completed
Patient information material
Target number of participants 45000
Interventions In the PROHTECT trial, the effect of the addition of offering self-sampling at home to women who are not responding to the invitation of the regular cervical screening program as well as a first recall, onto the participation rate is evaluated in a randomised controlled trial design.

During the trial, participants will receive either a second recall for the regular screening (control group), or receive a kit for self-sampling of a cervicovaginal specimen at home and subsequent referral recommendations based on the presence or absence of high-risk Human PapillomaVirus (hrHPV) in the self-taken specimen (intervention group, hrHPV test results disclosed).
Primary outcome measure(s) The primary outcome measure is the change in compliance rate, i.e., the increase in attendance rate of the cervical screening program after a second recall by using self-sampling material for hrHPV testing, compared to a control group that will receive a second recall for cytological testing (similar to the conventional first recall).
Secondary outcome measure(s) The secondary outcome measures include:
1. The women characteristics, i.e., the prevalence of HPV and the number of detected high-grade CIN lesions for compliance of referral and treatment among non-responder women compared to women participating in the conventional screening program.
2. Evaluation of the cost-effectiveness of self-sampling when offered in the nation-wide screening program, i.e., counter valuation of the effects on costs versus improved detection rate of premalignant lesions.
Sources of funding 1. Comprehensive Cancer Centre (Integraal Kankercentrum) (The Netherlands) 2. VU University Medical Center (The Netherlands) 3. National Institute of Public Health and Environmental Protection (RIVM) (The Netherlands)
Trial website http://www.hpvthuistest.nl
Publications Brink et al. J Clin Microbiol. 2006; 44:2518-23.
Bais et al. Int. J. Cancer submitted
Contact name Dr  D A M  Heideman
  Address VU University Medical Center
Department of Pathology
P.O. Box 7057
  City/town Amsterdam
  Zip/Postcode 1007 MB
  Country Netherlands
  Email dam.heideman@vumc.nl
Sponsor VU University Medical Center (The Netherlands)
  Address Department of Pathology
P.O. Box 7057
  City/town Amsterdam
  Zip/Postcode 1007 MB
  Country Netherlands
  Email cjlm.meijer@vumc.nl
  Sponsor website: http://www.vumc.nl/
Date applied 28/12/2006
Last edited 04/01/2007
Date ISRCTN assigned 28/12/2006
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