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

May 13, 2024 updated by: Joakim Dillner, Karolinska Institutet

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

270000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 141 86
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cervical intraepithelial neoplasia 2+ (CIN2+)
Time Frame: first evaluation, the 1 of january 2013
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
Time Frame: first evaluation, 1 of January 2013
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
Invasive cervical cancer
Time Frame: first evaluation, after 2nd round of screening, approximately 8 years after enrollment
The number of women with invasive cervical cancer detected in the two arms.
first evaluation, after 2nd round of screening, approximately 8 years after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Region Stockholm

Investigators

  • Principal Investigator: Joakim Dillner, MD, PhD, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Actual)

June 30, 2017

Study Completion (Estimated)

December 1, 2031

Study Registration Dates

First Submitted

December 20, 2011

First Submitted That Met QC Criteria

January 12, 2012

First Posted (Estimated)

January 18, 2012

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 13, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLL-KI-HPV

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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