Contact information
Type
Scientific
Primary contact
Dr D A M Heideman
ORCID ID
Contact details
VU University Medical Center
Department of Pathology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
dam.heideman@vumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2006/01WBO
Study information
Scientific title
Acronym
PROHTECT
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)?
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Screening
Patient information sheet
Condition
Cervical Intraepithelial Neoplasia (CIN), cervix cancer, uterus
Intervention
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).
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 measures
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.
Overall trial start date
01/10/2006
Overall trial end date
01/03/2009
Reason abandoned
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
45000
Participant 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
Recruitment start date
01/10/2006
Recruitment end date
01/03/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
VU University Medical Center
Amsterdam
1007 MB
Netherlands
Sponsor information
Organisation
VU University Medical Center (The Netherlands)
Sponsor details
Department of Pathology
P.O. Box 7057
Amsterdam
1007 MB
Netherlands
cjlm.meijer@vumc.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
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)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Brink et al. J Clin Microbiol. 2006; 44:2518-23.
Bais et al. Int. J. Cancer submitted