NCT00479375

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

Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Screening

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12,527 (actual)
• Sponsor: Skane University Hospital · Academic / Other
• Sex: Female
• Age: 32 Years – 38 Years
• Healthy volunteers: Accepted

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+).

Conditions

• Cervical Cancer
• Cervical Intraepithelial Neoplasia

Interventions

Type	Name	Description
PROCEDURE	Adding Human Papillomavirus testing to organised cervical screening

Timeline

• Start date: 1997-05-01
• Completion: 2007-05-01
• First posted: 2007-05-28
• Last updated: 2007-05-28

Locations

1 site across 1 country: Sweden