Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Cancer Screening - Full Text View

Sponsors and Collaborators:	Malmö University Hospital Swedish Cancer Society Europe Against Cancer (European Union Directorate General XII- Public Health)
Information provided by:	Malmö University Hospital
ClinicalTrials.gov Identifier:	NCT00479375

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

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Screening, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Controlled Trial of Human Papillomavirus Testing in Primary Cervical Screening

Further study details as provided by Malmö 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00479375

Locations

Sweden
Malmo University Hospital
Malmo, Sweden, SE-20502

Sponsors and Collaborators

Malmö 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:

Elfgren K, Rylander E, Radberg T, Strander B, Strand A, Paajanen K, Sjoberg I, Ryd W, Silins I, Dillner J; Swedescreen Study Group. Colposcopic and histopathologic evaluation of women participating in population-based screening for human papillomavirus deoxyribonucleic acid persistence. Am J Obstet Gynecol. 2005 Sep;193(3 Pt 1):650-7.

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.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Naucler P, Ryd W, Tornberg S, Strand A, Wadell G, Elfgren K, Radberg T, Strander B, Forslund O, Hansson BG, Rylander E, Dillner J. Human papillomavirus and Papanicolaou tests to screen for cervical cancer. N Engl J Med. 2007 Oct 18;357(16):1589-97.

Study ID Numbers:	3824-B00-05XAC
Study First Received:	May 25, 2007
Last Updated:	May 25, 2007
ClinicalTrials.gov Identifier:	NCT00479375 History of Changes
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Malmö University Hospital:

screening
human papillomavirus

Study placed in the following topic categories:

Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Carcinoma
Cervical Intraepithelial Neoplasia

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Histologic Type
Carcinoma in Situ

Neoplasms, Glandular and Epithelial
Carcinoma
Cervical Intraepithelial Neoplasia

ClinicalTrials.gov processed this record on May 07, 2009