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

NCT01511328 | Active Not Recruiting

• 1 other identifier: SLL-KI-HPV
• Study Type: interventional
• Target: 270,000
• Locations: 1 country
• Sites: 1

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.

Conditions

High-grade Cervical Intraepithelial Neoplasia; Invasive Cervical Cancer

Keywords

HPV testing; Primary screening; Cervical Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Cost for the two different diagnostic procedures

  first evaluation, 1 of January 2013

• Invasive cervical cancer

  first evaluation, after 2nd round of screening, approximately 8 years after enrollment

Study Arms (2)

HPV testing

EXPERIMENTAL

Women randomised to this arm get primary HPV testing

Other: HPV testing

cytology

NO INTERVENTION

women included follow the standard procedure with primary cytology

Interventions

HPV testing OTHER

Testing for Human Papilloma Virus

HPV testing

Eligibility Criteria

• Age: 30 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, 141 86, Sweden

Location

Related Publications (8)

• 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.

  PMID: 19796748 BACKGROUND

• 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.

  PMID: 19141778 BACKGROUND

• 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: 10.1136/bmjopen-2016-014788.

  PMID: 28566363 RESULT

• 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.1003748. eCollection 2021 Aug.

  PMID: 34424907 RESULT

• Yao Q, Wang J, Elfstrom KM, Strander B, Dillner J, Sundstrom K. Evaluation of primary HPV-based cervical screening among older women: Long-term follow-up of a randomized healthcare policy trial in Sweden. PLoS Med. 2024 Dec 19;21(12):e1004505. doi: 10.1371/journal.pmed.1004505. eCollection 2024 Dec.

  PMID: 39700313 DERIVED

• Wang J, Elfstrom KM, Dillner J. Human papillomavirus-based cervical screening and long-term cervical cancer risk: a randomised health-care policy trial in Sweden. Lancet Public Health. 2024 Nov;9(11):e886-e895. doi: 10.1016/S2468-2667(24)00218-4.

  PMID: 39486904 DERIVED

• Wang J, Elfstrom KM, Lagheden C, Eklund C, Sundstrom K, Sparen P, Dillner J. Impact of cervical screening by human papillomavirus genotype: Population-based estimations. PLoS Med. 2023 Oct 27;20(10):e1004304. doi: 10.1371/journal.pmed.1004304. eCollection 2023 Oct.

  PMID: 37889928 DERIVED

• Sahlgren H, Elfstrom KM, Lamin H, Carlsten-Thor A, Eklund C, Dillner J, Elfgren K. Colposcopic and histopathologic evaluation of women with HPV persistence exiting an organized screening program. Am J Obstet Gynecol. 2020 Mar;222(3):253.e1-253.e8. doi: 10.1016/j.ajog.2019.09.039. Epub 2019 Oct 1.

  PMID: 31585095 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Joakim Dillner, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: January 18, 2012
• Study Start: January 1, 2012
• Primary Completion: June 30, 2017
• Study Completion (Estimated): December 1, 2031
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

SE (1)