Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Cancer Screening (SWEDESCREEN)
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|ClinicalTrials.gov Identifier: NCT00479375|
Recruitment Status : Completed
First Posted : May 28, 2007
Last Update Posted : May 28, 2007
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+).
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Cervical Intraepithelial Neoplasia||Procedure: Adding Human Papillomavirus testing to organised cervical screening||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12527 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Screening|
|Study Start Date :||May 1997|
|Actual Study Completion Date :||May 2007|
- 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). [ Time Frame: On average 4 years post baseline ]
- 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. [ Time Frame: On average 4 years post baseline ]
- Re-analysis of primary and secondary outcomes also after subsequent 3-yearly screening rounds [ Time Frame: On average 7, 10, 13 (et cetera) years post base-line ]
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00479375
|Malmo University Hospital|
|Malmo, Sweden, SE-20502|
|Principal Investigator:||Joakim Dillner, MD||Malmo University Hospital, Lund University|