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

This study is currently recruiting participants. (see Contacts and Locations)
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

January 27, 2010
May 31, 2011
June 2010
June 2017   (final data collection date for primary outcome measure)
Histological CIN2, CIN3 and cervical carcinoma [ Time Frame: At baseline and each subsequent follow-up ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01058460 on ClinicalTrials.gov Archive Site
Clearance of mild cervical abnormalities among HPV negative subjects [ Time Frame: At baseline and 1-year after ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Cervical Cancer
  • Cervical Intraepithelial Neoplasia
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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12000
June 2017
June 2017   (final data collection date for primary outcome measure)

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
Female
30 Years to 60 Years
Yes
Contact: Hextan YS Ngan, MD, MBBS 852-2255-4684 hysngan@hkusua.hku.hk
China
 
NCT01058460
UW09-377
Not Provided
Professor Hextan Y.S. Ngan, Department of Obstetrics & Gynaecology, The University of Hong Kong
The University of Hong Kong
The Family Planning Association of Hong Kong
Principal Investigator: Hextan YS Ngan, MD, MBBS Department of Obstetrics & Gynaecology, The University of Hong Kong
The University of Hong Kong
May 2011

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