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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01511328
First Posted: January 18, 2012
Last Update Posted: March 3, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Joakim Dillner, Karolinska Institutet
  Purpose
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.

Condition Intervention
High-grade Cervical Intraepithelial Neoplasia Other: HPV testing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Randomized Implementation of Primary Human Papillomavirus (HPV) Testing in the Organized Screening for Cervical Cancer in Stockholm

Resource links provided by NLM:


Further study details as provided by Joakim Dillner, Karolinska Institutet:

Primary Outcome Measures:
  • number of CIN 2+ cases for the two different diagnostic procedures [ 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


Secondary Outcome Measures:
  • calculation of 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


Enrollment: 270000
Study Start Date: January 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01511328


Locations
Sweden
Karolinska University Hospital
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
Investigators
Principal Investigator: Joakim Dillner, MD, PhD Karolinska Institutet
  More Information

Publications:
Responsible Party: Joakim Dillner, Professor of infectious disease epidemiology, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01511328     History of Changes
Other Study ID Numbers: SLL-KI-HPV
First Submitted: December 20, 2011
First Posted: January 18, 2012
Last Update Posted: March 3, 2017
Last Verified: March 2017

Keywords provided by Joakim Dillner, Karolinska Institutet:
HPV testing
Primary screening
Cervical Cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type