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

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ClinicalTrials.gov Identifier: NCT00479375
Recruitment Status : Completed
First Posted : May 28, 2007
Last Update Posted : May 28, 2007
Sponsor:
Collaborators:
Swedish Cancer Society
Europe Against Cancer (European Union Directorate General XII- Public Health)
Information provided by:
Skane University Hospital

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+).


Condition or disease Intervention/treatment Phase
Cervical Cancer Cervical Intraepithelial Neoplasia Procedure: Adding Human Papillomavirus testing to organised cervical screening Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12527 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Screening
Official Title: Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Screening
Study Start Date : May 1997
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]


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

Inclusion Criteria:

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

Exclusion Criteria:

  • Not providing informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00479375


Locations
Sweden
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)
Investigators
Principal Investigator: Joakim Dillner, MD Malmo University Hospital, Lund University

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00479375     History of Changes
Other Study ID Numbers: 3824-B00-05XAC
First Posted: May 28, 2007    Key Record Dates
Last Update Posted: May 28, 2007
Last Verified: May 2007

Keywords provided by Skane University Hospital:
screening
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
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type