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

Karolinska Institute

Status: Active, not recruiting

Conditions: Invasive Cervical Cancer; High-grade Cervical Intraepithelial Neoplasia

Treatments: Other: HPV testing

Study type: Interventional

Funder types: Other

Identifiers

NCT01511328

SLL-KI-HPV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 270,000 patients

Sex: Female

Ages: 30 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270,000 participants in 2 patient groups

HPV testing

Experimental group

Description:

Women randomised to this arm get primary HPV testing

Treatment:

Other: HPV testing

cytology

No Intervention group

Description:

women included follow the standard procedure with primary cytology