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

Sponsor

The University of Hong Kong (Other)

Overall Status

Unknown status

CT.gov ID

NCT01058460

Collaborator

The Family Planning Association of Hong Kong (Other)

12,000

Enrollment

Location

Arms

Duration (Months)

142.8

Patients Per Site Per Month

Study Details

Study Description

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:

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.
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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer Cervical Intraepithelial Neoplasia	Procedure: HPV-cytology co-testing	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jun 1, 2010

Anticipated Primary Completion Date :

Jun 1, 2017

Anticipated Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: cytology Subjects in the control arm will receive conventional cytology testing and HPV testing at baseline. Follow up management will be based on the cytology result according to current practice.
Experimental: HPV-cytology Subjects in the HPV-cytology arm will receive HPV testing and cytology testing at baseline. Follow up management will be based on both results.	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.

Arm

Intervention/Treatment

No Intervention: cytology

Subjects in the control arm will receive conventional cytology testing and HPV testing at baseline. Follow up management will be based on the cytology result according to current practice.

Experimental: HPV-cytology

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

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.

Outcome Measures

Primary Outcome Measures

Histological CIN2, CIN3 and cervical carcinoma [At baseline and each subsequent follow-up]

Secondary Outcome Measures

Clearance of mild cervical abnormalities among HPV negative subjects [At baseline and 1-year after]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 60 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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