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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Karolinska Institutet
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Joakim Dillner, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01511328
First received: December 20, 2011
Last updated: March 31, 2015
Last verified: March 2015
  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: 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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The cost for the new procedure with HPV test in primary screening will be compared to the routine procedure with primary cytology


Estimated Enrollment: 100000
Study Start Date: January 2012
Estimated Primary Completion Date: December 2016 (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

Ages Eligible for Study:   30 Years to 64 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01511328

Contacts
Contact: Sven Törnberg, MD, PhD 46-8-51773194 Sven.tornberg@karolinska.se

Locations
Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden, 141 86
Contact: Mikael Björnstedt, MD, PhD    +46-8-58583809    Mikael.Bjornstedt@karolinska.se   
Principal Investigator: Joakim Dillner, MD, PhD         
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
Study First Received: December 20, 2011
Last Updated: March 31, 2015
Health Authority: Sweden: Regional Ethical Review Board
Sweden: Swedish Research Council

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

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

ClinicalTrials.gov processed this record on August 02, 2015