Cervical intraepithelial neoplasia (CIN), Cervix cancer
Conditions
Interventions
This randomized-controlled trial is coordinated by the Radboud University Medical Centre (RUMC) and performed in collaboration with VUmc, the screening organizations Mid-West and East and RIVM. In the
Sponsors
Radboud University Nijmegen Medical Centre, department of Obstetrics and Gynaecology, VU University Medical Center, Department of Pathology, National Institute for Public Health and the Environment (RIVM), Screening organization Mid-West, Screening organization East.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women invited for the cervical cancer screening program in 2008 (ages 30-60 years), who did not respond to an initial invitation and a recall after 3-6 months; 2. Women should reside in the regions covered by district health authorities of Noord-Holland, Flevoland, Utrecht and Gelderland (in the Netherlands).
Exclusion criteria
Exclusion criteria: 1. Not in the population based screening program, i.e. ages under 30 years, or over 60 years; 2. Actively responded to the invitation or recall of the cervical screening program by undergoing a cervical smear at the general practitioner; 3. Under follow-up by gynaecologist for previous abnormal cytology, and/or CIN3 lesion or worse less than 2 years before inclusion; 4. Current pregnancy; 5. Status after hysterectomy or amputation of the portio.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participation rate of women in both study arms. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. User comfort of both self-sample devices; 2. The number of CIN 2+ and CIN 3+ lesions in both study arms; 3. hrHPV prevalence in both study arms; 4. Compliance in follow-up after a positive hrHPV result. | — |
Contacts
Public ContactR.P. Bosgraaf
Radboud University Nijmegen Medical Centre Department of Obstetrics & Gynaecology (791) P.O. box 9101
Outcome results
None listed