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

Not Applicable

Completed

• Conditions: Cervical Cancer; Cervical Intraepithelial Neoplasia

• Registration Number: NCT00479375
• Lead Sponsor: Skane University Hospital

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+).

Detailed Description

Not available

Study Timeline

• Study Start: 1997-05
• Status Verified: 2007-05
• Study Completion: 2007-05
• Study First Submitted: 2007-05-25
• Study First Submitted QC: 2007-05-25
• Last Update Submitted: 2007-05-25
• Study First Posted: 2007-05-28
• Last Update Posted: 2007-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12527

Inclusion Criteria

• Women aged 32-38 years old
• Attending the Swedish population-based organised cervical screening program

Exclusion Criteria

• Not providing informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Malmo University Hospital; 🇸🇪 Malmo, Sweden