MedTrace Logo

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

NCT00479375 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12527

Last updated 2007-05-28

No results posted yet for this study

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+).

Conditions

Interventions

PROCEDURE

Adding Human Papillomavirus testing to organised cervical screening

Sponsors & Collaborators

  • Swedish Cancer Society

    collaborator OTHER

  • Europe Against Cancer (European Union Directorate General XII- Public Health)

    collaborator UNKNOWN

  • Skane University Hospital

    lead OTHER

Principal Investigators

  • Joakim Dillner, MD · Malmo University Hospital, Lund University

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
32 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1997-05-31
Completion
2007-05-31

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00479375 on ClinicalTrials.gov