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

Cervical Cancer Clinical Trial

— SWEDESCREEN  

Official title:

Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00479375
• Other study ID #: 3824-B00-05XAC
• Status: Completed
• Phase: N/A
• First received: May 25, 2007
• Last updated: May 25, 2007
• Start date: May 1997
• Est. completion date: May 2007

Study information

• Verified date: May 2007
• Source: Skane University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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+).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12527
• Est. completion date: May 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 32 Years to 38 Years

Eligibility

Inclusion Criteria:

• Women aged 32-38 years old

• Attending the Swedish population-based organised cervical screening program

Exclusion Criteria:

• Not providing informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Screening

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Adding Human Papillomavirus testing to organised cervical screening

Locations

Country	Name	City	State
Sweden	Malmo University Hospital	Malmo

Sponsors (3)

Lead Sponsor	Collaborator
Skane University Hospital	Europe Against Cancer (European Union Directorate General XII- Public Health), Swedish Cancer Society

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Elfgren K, Rylander E, Rådberg T, Strander B, Strand A, Paajanen K, Sjöberg I, Ryd W, Silins I, Dillner J; Swedescreen Study Group. Colposcopic and histopathologic evaluation of women participating in population-based screening for human papillomavirus de — View Citation

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. Erratum in: J Med Virol 2002 Jul;67(3):467. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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