Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Cancer Screening

NCT00479375 | Completed DMC

• 1 other identifier: 3824-B00-05XAC
• Study Type: interventional
• Target: 12,527
• Locations: 1 country
• Sites: 1

Brief Summary

Human papillomavirus (HPV)-based cervical screening is known to increase sensitivity for detection of high-grade cervical intraepithelial neoplasia (CIN). Randomized trials of longitudinal efficacy are required to assess whether these gains represent overdiagnosis or a protective effect. Methods: A total of 12527 women, aged 32-38, attending population-based invitational screening in Sweden were randomized 1:1 to HPV test and cytology (intervention arm) or cytology only (control arm). HPV-positive women were invited for a second HPV test at least one year later and women with type-specific persistent infections were then invited to colposcopy. A similar number of random double-blinded procedures are performed in the control arm. Women are followed with comprehensive registry-based follow-up. Primary outcome is the relative rates of CIN grade 2 or worse (CIN2/CIN3+) found in subsequent screening. Secondary outcomes are the relative rates of CIN2/CIN3+ found in the aseline screening and outcomes stratified by grade of CIN (CIN 2 or CIN3+).

Conditions

Cervical Cancer; Cervical Intraepithelial Neoplasia

Keywords

screening; human papillomavirus

Outcome Measures

Primary Outcomes (1)

• Incidence of CIN2/CIN3+ lesions (which includes invasive cancers and in situ adenocarcinomas) found by subsequent screening (i.e. after the enrollment screening round and its associated follow-up).

  On average 4 years post baseline

Secondary Outcomes (2)

• Secondary outcomes were the incidence of CIN2/CIN3+ lesions at enrollment screening (including associated follow-up) and outcomes stratified by CIN2 and CIN3+ lesions as endpoints.

  On average 4 years post baseline

• Re-analysis of primary and secondary outcomes also after subsequent 3-yearly screening rounds

  On average 7, 10, 13 (et cetera) years post base-line

Interventions

Adding Human Papillomavirus testing to organised cervical screening PROCEDURE

Eligibility Criteria

• Age: 32 Years - 38 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged 32-38 years old
• Attending the Swedish population-based organised cervical screening program

You may not qualify if:

• Not providing informed consent

Sponsors & Collaborators

• Skane University Hospital: lead
• Swedish Cancer Society: collaborator
• Europe Against Cancer (European Union Directorate General XII- Public Health): collaborator

Study Sites (1)

Malmo University Hospital

Malmo, SE-20502, Sweden

Location

Related Publications (5)

• Forslund O, Antonsson A, Edlund K, van den Brule AJ, Hansson BG, Meijer CJ, Ryd W, Rylander E, Strand A, Wadell G, Dillner J, Johansson B. Population-based type-specific prevalence of high-risk human papillomavirus infection in middle-aged Swedish women. J Med Virol. 2002 Apr;66(4):535-41. doi: 10.1002/jmv.2178.

  PMID: 11857534 BACKGROUND

• Elfgren K, Rylander E, Radberg T, Strander B, Strand A, Paajanen K, Sjoberg I, Ryd W, Silins I, Dillner J; Swedescreen Study Group. Colposcopic and histopathologic evaluation of women participating in population-based screening for human papillomavirus deoxyribonucleic acid persistence. Am J Obstet Gynecol. 2005 Sep;193(3 Pt 1):650-7. doi: 10.1016/j.ajog.2005.01.056.

  PMID: 16150255 RESULT

• 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

• Elfstrom KM, Smelov V, Johansson AL, Eklund C, Naucler P, Arnheim-Dahlstrom L, Dillner J. Long term duration of protective effect for HPV negative women: follow-up of primary HPV screening randomised controlled trial. BMJ. 2014 Jan 16;348:g130. doi: 10.1136/bmj.g130.

  PMID: 24435414 DERIVED

• Naucler P, Ryd W, Tornberg S, Strand A, Wadell G, Elfgren K, Radberg T, Strander B, Johansson B, Forslund O, Hansson BG, Rylander E, Dillner J. Human papillomavirus and Papanicolaou tests to screen for cervical cancer. N Engl J Med. 2007 Oct 18;357(16):1589-97. doi: 10.1056/NEJMoa073204.

  PMID: 17942872 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Cervical Dysplasia

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; Precancerous Conditions

Study Officials

• Joakim Dillner, MD

  Malmo University Hospital, Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 25, 2007
• First Posted: May 28, 2007
• Study Start: May 1, 1997
• Study Completion: May 1, 2007
• Last Updated: May 28, 2007

Record last verified: 2007-05

Locations

SE (1)