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

This study has been completed.
Swedish Cancer Society
Europe Against Cancer (European Union Directorate General XII- Public Health)
Information provided by:
Skane University Hospital Identifier:
First received: May 25, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted

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+).

Condition Intervention
Cervical Cancer
Cervical Intraepithelial Neoplasia
Procedure: Adding Human Papillomavirus testing to organised cervical screening

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Screening
Official Title: Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Screening

Resource links provided by NLM:

Further study details as provided by Skane University Hospital:

Primary Outcome Measures:
  • 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). [ Time Frame: On average 4 years post baseline ]

Secondary Outcome Measures:
  • 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. [ Time Frame: On average 4 years post baseline ]
  • Re-analysis of primary and secondary outcomes also after subsequent 3-yearly screening rounds [ Time Frame: On average 7, 10, 13 (et cetera) years post base-line ]

Enrollment: 12527
Study Start Date: May 1997
Study Completion Date: May 2007

Ages Eligible for Study:   32 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  • Not providing informed consent
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Please refer to this study by its identifier: NCT00479375

Malmo University Hospital
Malmo, Sweden, SE-20502
Sponsors and Collaborators
Skane University Hospital
Swedish Cancer Society
Europe Against Cancer (European Union Directorate General XII- Public Health)
Principal Investigator: Joakim Dillner, MD Malmo University Hospital, Lund University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00479375     History of Changes
Other Study ID Numbers: 3824-B00-05XAC
Study First Received: May 25, 2007
Last Updated: May 25, 2007

Keywords provided by Skane University Hospital:
human papillomavirus

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type processed this record on May 25, 2017