Cervical Cancer, Cervical Intraepithelial Neoplasia
Conditions
Keywords
screening, human papillomavirus
Brief summary
Human papillomavirus (HPV)-based cervical screening is known to increase sensitivity for detection of high-grade cervical intraepithelial neoplasia (CIN). Randomized trials of longitudinal efficacy are required to assess whether these gains represent overdiagnosis or a protective effect. Methods: A total of 12527 women, aged 32-38, attending population-based invitational screening in Sweden were randomized 1:1 to HPV test and cytology (intervention arm) or cytology only (control arm). HPV-positive women were invited for a second HPV test at least one year later and women with type-specific persistent infections were then invited to colposcopy. A similar number of random double-blinded procedures are performed in the control arm. Women are followed with comprehensive registry-based follow-up. Primary outcome is the relative rates of CIN grade 2 or worse (CIN2/CIN3+) found in subsequent screening. Secondary outcomes are the relative rates of CIN2/CIN3+ found in the aseline screening and outcomes stratified by grade of CIN (CIN 2 or CIN3+).
Interventions
PROCEDUREAdding Human Papillomavirus testing to organised cervical screening
Sponsors
Swedish Cancer Society
Europe Against Cancer (European Union Directorate General XII- Public Health)
Skane University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
32 Years to 38 Years
Healthy volunteers
Yes
Inclusion criteria
* Women aged 32-38 years old * Attending the Swedish population-based organised cervical screening program
Exclusion criteria
* Not providing informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of CIN2/CIN3+ lesions (which includes invasive cancers and in situ adenocarcinomas) found by subsequent screening (i.e. after the enrollment screening round and its associated follow-up). | On average 4 years post baseline |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes were the incidence of CIN2/CIN3+ lesions at enrollment screening (including associated follow-up) and outcomes stratified by CIN2 and CIN3+ lesions as endpoints. | On average 4 years post baseline |
| Re-analysis of primary and secondary outcomes also after subsequent 3-yearly screening rounds | On average 7, 10, 13 (et cetera) years post base-line |
Countries
Sweden
Outcome results
None listed