Clinical trial · Interventional
Randomized Implementation of Primary HPV Testing in the Organized Screening for Cervical Cancer in Stockholm
Randomized Implementation of Primary Human Papillomavirus (HPV) Testing in the Organized Screening for Cervical Cancer in Stockholm
NCT01511328CI-TRIAL-00077193active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| High-grade Cervical Intraepithelial Neoplasia | High Grade Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Invasive Cervical Cancer | Invasive Cervical Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HPV testing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HPV testing
- description
- Women randomised to this arm get primary HPV testing
- interventionNames
- Other: HPV testing
- type
- NO_INTERVENTION
- label
- cytology
- description
- women included follow the standard procedure with primary cytology
Primary outcomes (1)
- measure
- Cervical intraepithelial neoplasia 2+ (CIN2+)
- timeFrame
- first evaluation, the 1 of january 2013
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: Women between the age 30 and 64 years resident in the Stockholm-Gotland region. No exclusion criteria.
References
Publications (8)
- BACKGROUNDArbyn 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
- BACKGROUNDNaucler 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
- RESULTLamin 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
- RESULTElfstrom 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
- DERIVEDYao 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
- DERIVEDWang 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
- 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.