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

This study is currently recruiting participants.

Verified May 2011 by The University of Hong Kong

Sponsor:

Collaborator:

The Family Planning Association of Hong Kong

Information provided by:

The University of Hong Kong

ClinicalTrials.gov Identifier:

NCT01058460

First received: January 27, 2010

Last updated: May 31, 2011

Last verified: May 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 27, 2010

Last Updated Date

May 31, 2011

Start Date ^ICMJE

June 2010

Estimated Primary Completion Date

June 2017 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Histological CIN2, CIN3 and cervical carcinoma [ Time Frame: At baseline and each subsequent follow-up ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01058460 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Clearance of mild cervical abnormalities among HPV negative subjects [ Time Frame: At baseline and 1-year after ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Cervical Cancer
Cervical Intraepithelial Neoplasia

Intervention ^ICMJE

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.

Study Arm (s)

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.

Intervention: Procedure: HPV-cytology co-testing

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

12000

Estimated Completion Date

June 2017

Estimated Primary Completion Date

June 2017 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

30 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Hextan YS Ngan, MD, MBBS

852-2255-4684

hysngan@hkusua.hku.hk

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01058460

Other Study ID Numbers ^ICMJE

UW09-377

Has Data Monitoring Committee

Not Provided

Responsible Party

Professor Hextan Y.S. Ngan, Department of Obstetrics & Gynaecology, The University of Hong Kong

Study Sponsor ^ICMJE

The University of Hong Kong

Collaborators ^ICMJE

The Family Planning Association of Hong Kong

Investigators ^ICMJE

Principal Investigator:

Hextan YS Ngan, MD, MBBS

Department of Obstetrics & Gynaecology, The University of Hong Kong

Information Provided By

The University of Hong Kong

Verification Date

May 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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