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

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ClinicalTrials.gov Identifier: NCT01511328
Recruitment Status : Unknown
Verified March 2017 by Joakim Dillner, Karolinska Institutet.
Recruitment status was:  Active, not recruiting
First Posted : January 18, 2012
Last Update Posted : March 3, 2017
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Joakim Dillner, Karolinska Institutet

Tracking Information
First Submitted Date  ICMJE December 20, 2011
First Posted Date  ICMJE January 18, 2012
Last Update Posted Date March 3, 2017
Study Start Date  ICMJE January 2012
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01511328 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 12, 2012)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Implementation of Primary HPV Testing in the Organized Screening for Cervical Cancer in Stockholm
Official Title  ICMJE Randomized Implementation of Primary Human Papillomavirus (HPV) Testing in the Organized Screening for Cervical Cancer in Stockholm
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE High-grade Cervical Intraepithelial Neoplasia
Intervention  ICMJE Other: HPV testing
Testing for Human Papilloma Virus
Study Arms  ICMJE
  • Experimental: HPV testing
    Women randomised to this arm get primary HPV testing
    Intervention: Other: HPV testing
  • No Intervention: cytology
    women included follow the standard procedure with primary cytology
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: August 29, 2016)
270000
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01511328
Other Study ID Numbers  ICMJE SLL-KI-HPV
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joakim Dillner, Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE Stockholm County Council, Sweden
Investigators  ICMJE
Principal Investigator: Joakim Dillner, MD, PhD Karolinska Institutet
PRS Account Karolinska Institutet
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP