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

Not Applicable

• Conditions: Cervical Cancer; Cervical Intraepithelial Neoplasia
• Interventions: Procedure: HPV-cytology co-testing

• Registration Number: NCT01058460
• Lead Sponsor: The University of Hong Kong

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-01-27
• Study First Submitted QC: 2010-01-27
• Study First Posted: 2010-01-28
• Study Start: 2010-06
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-31
• Last Update Posted: 2011-06-01
• Primary Completion: 2017-06
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 12000

Inclusion Criteria

• Ethnic Chinese women aged 30 to 60 years who have completed a written consent
• Women who have not attended screening for the past 3 years or more will be given priority

Exclusion Criteria

• Currently pregnant
• Without a cervix
• Congenital abnormalities of the lower genital tract
• Previous history of invasive cervical cancer
• Who has been followed-up or treated for an abnormal cytology result in the past 12 months
• Who are unable to provide consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HPV-cytology	HPV-cytology co-testing	Subjects in the HPV-cytology arm will receive HPV testing and cytology testing at baseline. Follow up management will be based on both results.

Primary Outcome Measures

Name	Time	Method
Histological CIN2, CIN3 and cervical carcinoma	At baseline and each subsequent follow-up

Secondary Outcome Measures

Name	Time	Method
Clearance of mild cervical abnormalities among HPV negative subjects	At baseline and 1-year after

Trial Locations

Locations (1)

Department of Obstetrics & Gynaecology, The University of Hong Kong; 🇨🇳 Hong Kong SAR, China