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

High-grade Cervical Intraepithelial Neoplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01511328
• Other study ID #: SLL-KI-HPV
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2012
• Est. completion date: December 2031

Study information

• Verified date: May 2024
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 270000
• Est. completion date: December 2031
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 64 Years

Eligibility

Inclusion Criteria:

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

Related Conditions & MeSH terms

• High-grade Cervical Intraepithelial Neoplasia
• Uterine Cervical Dysplasia
• Uterine Cervical Neoplasms

Intervention

Other:
• HPV testing
Testing for Human Papilloma Virus

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Region Stockholm

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

Arbyn M, Ronco G, Meijer CJ, Naucler P. Trials comparing cytology with human papillomavirus screening. Lancet Oncol. 2009 Oct;10(10):935-6. doi: 10.1016/S1470-2045(09)70296-7. No abstract available. — View Citation

Elfstrom KM, Eklund C, Lamin H, Ohman D, Hortlund M, Elfgren K, Sundstrom K, Dillner J. Organized primary human papillomavirus-based cervical screening: A randomized healthcare policy trial. PLoS Med. 2021 Aug 23;18(8):e1003748. doi: 10.1371/journal.pmed. — View Citation

Lamin H, Eklund C, Elfstrom KM, Carlsten-Thor A, Hortlund M, Elfgren K, Tornberg S, Dillner J. Randomised healthcare policy evaluation of organised primary human papillomavirus screening of women aged 56-60. BMJ Open. 2017 May 30;7(5):e014788. doi: 10.113 — View Citation

Naucler P, Ryd W, Tornberg S, Strand A, Wadell G, Elfgren K, Radberg T, Strander B, Forslund O, Hansson BG, Hagmar B, Johansson B, Rylander E, Dillner J. Efficacy of HPV DNA testing with cytology triage and/or repeat HPV DNA testing in primary cervical cancer screening. J Natl Cancer Inst. 2009 Jan 21;101(2):88-99. doi: 10.1093/jnci/djn444. Epub 2009 Jan 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cervical intraepithelial neoplasia 2+ (CIN2+)	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	Cost for the two different diagnostic procedures	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
Secondary	Invasive cervical cancer	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