|- candidate number||2284|
|- NTR Number||NTR792|
|- Date ISRCTN created||28-dec-2006|
|- date ISRCTN requested||18-dec-2006|
|- Date Registered NTR||11-okt-2006|
|- Secondary IDs||2006/01WBO |
|- Public Title||Protection by Offering HPV Testing on self-sampled Cervicovaginal specimens Trial. |
|- Scientific Title||Offering hrHPV testing on self-sampled cervicovaginal specimens to women who are non-responder in the conventional cervical screening program.|
|- 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 HPV testing, and consequently the (cost-)effectiveness of screening will be enhanced due to increased detection of high grade CIN lesions or worse (>=CIN2-3) ?|
|- Healt Condition(s) or Problem(s) studied||Cervical intraepithelial neoplasia (CIN), Cervix cancer|
|- Inclusion criteria||1. Women invited for the cervical cancer screening program (ages 30-60 years), but who are not responding to their invitation as well as their recall (3 months after);
2. Residing in the region covered by district health authorities of North Holland and Flevoland (in the Netherlands).
|- 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 CIN3 lesion or worse less than 2 years before inclusion;
5. Current pregnancy;
6. Status after extirpation of the uterus or amputation of the portio.|
|- mec approval received||yes|
|- multicenter trial||no|
|- planned startdate ||1-okt-2006|
|- planned closingdate||1-mrt-2009|
|- 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 randomized 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 hrHPV in the self-taken specimen (intervention group, hrHPV test results disclosed).|
|- Primary outcome||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||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. |
|- Trial web site||http://www.hpvthuistest.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||PhD D.A.M. Heideman|
|- CONTACT for SCIENTIFIC QUERIES||Prof. C.J.L.M. Meijer|
|- Sponsor/Initiator ||VU University Medical Center, Department of Pathology, Comprehensive Cancer Center (IKA) Amsterdam , National Institute for Public Health and the Environment (RIVM)|
(Source(s) of Monetary or Material Support)
|Comprehensive Cancer Centre (Integraal Kankercentrum), VU University Medical Center, Department of Pathology, National Institute of Public Health and Environmental Protection (RIVM)|
|- Publications||Brink et al. J Clin Microbiol. 2006; 44:2518-23.
Bais et al. Int. J. Cancer submitted
|- Brief summary||After the introduction of cervical screening programs, cervical cancer incidence decreased impressively. Prevention of uterine cervical cancer is possible due to relatively slowly progressing premalignant lesions, i.e. the mean duration for development of cervical cancer is 13-15 years, that can be detected by cervical cytology or hrHPV-testing, and can be treated effectively. A major problem with current cervical screening programs, however, is that the compliance rate is subject to improvement. Even in well organized invitational programs by the National health authorities, attendance rates reach 63-65% with an additional 7 or 8% of 'passive response' or 'opportunistic screened' women. Almost 25%-30% of the invited women remained unprotected because they do not respond to the general screening invitation (these women are referred to as 'non-responders'). Most importantly, this fraction of unprotected women is responsible for 40-50% of all detected carcinomas.
Our pilot study (Bais et al.) has shown that offering a user-friendly self-sampling method for collecting cell material at home enabled the recruitment of about one-third of these women, who are otherwise unwilling or unable to submit to cytological screening, into the screening program. Consequently, a significant number of premalignant lesions were found. In this PROHTECT trial, we extend the evaluation of offering sampling at home with accompanied high-risk human papillomavirus (hrHPV) testing to the region North Holland and Flevoland in the Netherlands targeting 45.000 non-responders, aiming to reveal:
1)the effect on the attendance rate in the cervical screening program.
2)the non-responder characteristics (i.e., clinical features: percentage of hrHPV positivity and percentage of high grade CIN lesions or worse (>=CIN2-3) found) in comparison to women participating in the conventional screening program.
3)the cost-effectiveness of offering self-sampling in the nation-wide screening program
|- Main changes (audit trail)|
|- RECORD||11-okt-2006 - 29-dec-2006|