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

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

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01511328
Enrollment
270000
Registered
2012-01-18
Start date
2012-01-01
Completion date
2031-12-31
Last updated
2024-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High-grade Cervical Intraepithelial Neoplasia, Invasive Cervical Cancer

Keywords

HPV testing, Primary screening, Cervical Cancer

Brief summary

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

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. 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. 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.

Interventions

Testing for Human Papilloma Virus

Sponsors

Region Stockholm
CollaboratorOTHER_GOV
Karolinska Institutet
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
30 Years to 64 Years
Healthy volunteers
No

Inclusion criteria

Women between the age 30 and 64 years resident in the Stockholm-Gotland region. No

Exclusion criteria

.

Design outcomes

Primary

MeasureTime frameDescription
Cervical intraepithelial neoplasia 2+ (CIN2+)first evaluation, the 1 of january 2013The number of women with CIN2+ detected by primary HPV testing will be compared with the number of women with CIN2+ detected by primary cytology

Secondary

MeasureTime frameDescription
Cost for the two different diagnostic proceduresfirst evaluation, 1 of January 2013The cost for the new procedure with HPV test in primary screening will be compared to the routine procedure with primary cytology
Invasive cervical cancerfirst evaluation, after 2nd round of screening, approximately 8 years after enrollmentThe number of women with invasive cervical cancer detected in the two arms.

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026