Randomized Implementation of Primary HPV Testing in the Organized Screening for Cervical Cancer in Stockholm

Study Overview
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Brief Summary
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The purpose is to evaluate whether implementation of primary human papillomavirus (HPV) screening in the screening programme for cervical cancer improves the programme in terms of better cancer protection and better cost efficiency.

Detailed Description
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Primary HPV screening is a method with higher sensitivity than cytology for detection of high-grade cervical intraepithelial neoplasia, which is the precursor of cervical cancer. In particular, HPV test is a better test for revealing adenocarcinomas, since these cancers often show a normal cytology. Cervical cancer screening at age 60: Cytology is less effective in older women, and screening with cytology in women over 60 has no documented effect. Today a large part of cervical cancer develop in women older than 60, to whom no screening is offered. The prevalence of HPV is around 4% in this age group. Since we know that testing negative for HPV gives a better long-term protection against cervical cancer compared to cytology, primary screening for HPV in 60-year old women would give a longer lasting protection in this high-risk group compared with today. Cervical cancer screening at age 30-40: HPV screening is most cost effective above 35 years of age. The reason for this is that HPV is less prevalent at age 35 than in younger women and also because cervical cancer seldom develops before this age. Since the HPV test has a negative predictive value (NPV) of almost 100% this could lead to longer screening intervals, which would be improve cost-effectiveness.

Official Title
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Randomized Implementation of Primary Human Papillomavirus (HPV) Testing in the Organized Screening for Cervical Cancer in Stockholm

Conditions
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High-grade Cervical Intraepithelial Neoplasia

Intervention / Treatment
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* Other: HPV testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women between the age 30 and 64 years resident in the Stockholm-Gotland region. No exclusion criteria.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HPV testing<br>Women randomised to this arm get primary HPV testing | Other: HPV testing<br>* Testing for Human Papilloma Virus<br>|
| No Intervention: cytology<br>women included follow the standard procedure with primary cytology | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cervical intraepithelial neoplasia 2+ (CIN2+) | The number of women with CIN2+ detected by primary HPV testing will be compared with the number of women with CIN2+ detected by primary cytology | first evaluation, the 1 of january 2013 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost for the two different diagnostic procedures | The cost for the new procedure with HPV test in primary screening will be compared to the routine procedure with primary cytology | first evaluation, 1 of January 2013 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV testing, Primary screening, Cervical Cancer