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

This study has been completed.
Sponsor:
Collaborators:
Swedish Cancer Society
Europe Against Cancer (European Union Directorate General XII- Public Health)
Information provided by:
Skane University Hospital
ClinicalTrials.gov Identifier:
NCT00479375
First received: May 25, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
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
  Eligibility

Ages Eligible for Study:   32 Years to 38 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Additional 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
Study First Received: May 25, 2007
Last Updated: May 25, 2007
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Skane University Hospital:
screening
human papillomavirus

Additional relevant MeSH terms:
Carcinoma in Situ
Cervical Intraepithelial Neoplasia
Uterine Cervical Neoplasms
Carcinoma
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Uterine Neoplasms

ClinicalTrials.gov processed this record on October 29, 2014