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

May 31, 2011 updated by: The University of Hong Kong

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Hong Kong SAR, China
        • Recruiting
        • Department of Obstetrics & Gynaecology, The University of Hong Kong
        • Principal Investigator:
          • Hextan YS Ngan, MD, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Histological CIN2, CIN3 and cervical carcinoma
Time Frame: At baseline and each subsequent follow-up
At baseline and each subsequent follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Clearance of mild cervical abnormalities among HPV negative subjects
Time Frame: At baseline and 1-year after
At baseline and 1-year after

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

The Family Planning Association of Hong Kong

Investigators

  • Principal Investigator: Hextan YS Ngan, MD, MBBS, Department of Obstetrics & Gynaecology, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

January 27, 2010

First Submitted That Met QC Criteria

January 27, 2010

First Posted (Estimate)

January 28, 2010

Study Record Updates

Last Update Posted (Estimate)

June 1, 2011

Last Update Submitted That Met QC Criteria

May 31, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UW09-377

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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