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

Study Overview
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Brief Summary
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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+).

Official Title
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Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Screening

Conditions
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Cervical Cancer, Cervical Intraepithelial Neoplasia

Intervention / Treatment
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* Procedure: Adding Human Papillomavirus testing to organised cervical screening


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 32-38 years old Attending the Swedish population-based organised cervical screening program Exclusion Criteria: Not providing informed consent

Ages Eligible for Study
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Minimum Age: 32 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Adding Human Papillomavirus testing to organised cervical screening|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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screening, human papillomavirus