NCT01058460

HPV-cytology Testing Versus Cytology Testing for the Detection of High Grade CIN

A Randomized Controlled Trial Comparing Concomitant HPV-cytology Testing With Conventional Cytology Testing for the Detection of High Grade Cervical Intraepithelial Neoplasia in Primary Cervical Cancer Screening in Hong Kong

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12,000 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: Female
• Age: 30 Years – 60 Years
• Healthy volunteers: Accepted

Summary

To compare the effects of conventional cytology testing with concommitant HPV-cytology testing for the detection of high grade cervical lesions in primary cervical cancer screening in Hong Kong Hypotheses: 1. There is a significant difference in the number of CIN2+ cases detected between the cytology testing group and the cytology-HPV co-testing group at baseline. 2. Significantly more CIN2+ cases will be detected at the second round of screening among participants with normal cytology result in the control arm than those with normal cytology and negative HPV results in the intervention arm.

Conditions

• Cervical Cancer
• Cervical Intraepithelial Neoplasia

Interventions

Type	Name	Description
PROCEDURE	HPV-cytology co-testing	Subjects will receive HPV testing and conventional cytology testing at baseline. Follow up management will be based on both results.

Timeline

• Start date: 2010-06-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2010-01-28
• Last updated: 2011-06-01

Locations

1 site across 1 country: China