Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Cancer Screening (SWEDESCREEN)

Skane University Hospital

Status

Completed

Conditions

Cervical Intraepithelial Neoplasia

Cervical Cancer

Treatments

Procedure: Adding Human Papillomavirus testing to organised cervical screening

Study type

Interventional

Funder types

Other

Identifiers

NCT00479375

3824-B00-05XAC

Details and patient eligibility

About

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+).

Enrollment

12,527 patients

Sex

Female

Ages

32 to 38 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria