Cervical intraepithelial neoplasia (CIN), Cervix cancer
Conditions
Interventions
In the PROHTECT-2 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 rec
Sponsors
VU University Medical Center, Department of Pathology, Comprehensive Cancer Center (IKA) Amsterdam , National Institute for Public Health and the Environment (RIVM).
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 Noord-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 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; 2. Evaluation of the cost-effectiveness and feasibility of self-sampling when offered in the nation-wide screening program. | — |
Contacts
Public ContactD.A.M. Heideman
VU University Medical Center, Department of Pathology, P.O. Box 7700
Outcome results
None listed