Brief Title
Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Cancer Screening
Official Title
Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Screening
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+).
Study Type
Interventional
Primary Outcome
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).
Secondary Outcome
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.
Condition
Cervical Cancer
Intervention
Adding Human Papillomavirus testing to organised cervical screening
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
12527
Start Date
May 1997
Completion Date
May 2007
Eligibility Criteria
Inclusion Criteria:
- Women aged 32-38 years old
- Attending the Swedish population-based organised cervical screening program
Exclusion Criteria:
- Not providing informed consent
Gender
Female
Ages
32 Years - 38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Joakim Dillner, MD, ,
Location Countries
Sweden
Location Countries
Sweden
Administrative Informations
NCT ID
NCT00479375
Organization ID
3824-B00-05XAC
Study Sponsor
Skane University Hospital
Collaborators
Swedish Cancer Society
Study Sponsor
Joakim Dillner, MD, Principal Investigator, Malmo University Hospital, Lund University
Verification Date
May 2007