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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
  Purpose

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.

Condition Intervention
Cervical Cancer
Cervical Intraepithelial Neoplasia
 Procedure: HPV-cytology co-testing

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of Hong Kong:

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

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

Estimated Enrollment: 12000
Study Start Date: June 2010
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01058460

Contacts
Contact: Hextan YS Ngan, MD, MBBS 852-2255-4684 hysngan@hkusua.hku.hk

Locations
China
Department of Obstetrics & Gynaecology, The University of Hong Kong Recruiting
Hong Kong SAR, China
Principal Investigator: Hextan YS Ngan, MD, MBBS            
Sponsors and Collaborators
The University of Hong Kong
The Family Planning Association of Hong Kong
Investigators
Principal Investigator: Hextan YS Ngan, MD, MBBS Department of Obstetrics & Gynaecology, The University of Hong Kong
  More Information

No publications provided

Responsible Party: Professor Hextan Y.S. Ngan, Department of Obstetrics & Gynaecology, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01058460     History of Changes
Other Study ID Numbers: UW09-377
Study First Received: January 27, 2010
Last Updated: May 31, 2011
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
Cervical Intraepithelial Neoplasia, Grade III
Cervical Intraepithelial Neoplasia, Grade II

Additional relevant MeSH terms:
Neoplasms
Uterine Cervical Neoplasms
Cervical Intraepithelial Neoplasia
Carcinoma in Situ
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
 Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 22, 2013