Cervical Intraepithelial Neoplasia (CIN) Cervical cancer (CxCa)
Conditions
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 recal
Sponsors
VU University Medical Center, Department of Pathology, Amsterdam, The Netherlands;
IKA (Comprehensive Cancer Center Amsterdam);
RIVM (National Institute of Public Health and Environmental Protection)
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Contacts
Public ContactD.A.M. Heideman
VU University Medical Center, Department of Pathology, P.O. Box 7700
Outcome results
None listed