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

Primary Purpose

Cervical Cancer, Cervical Intraepithelial Neoplasia

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
HPV-cytology co-testing
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cervical Cancer focused on measuring Cervical Intraepithelial Neoplasia, Grade III, Cervical Intraepithelial Neoplasia, Grade II

Eligibility Criteria

30 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Obstetrics & Gynaecology, The University of Hong KongRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

cytology

HPV-cytology

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Histological CIN2, CIN3 and cervical carcinoma

Secondary Outcome Measures

Clearance of mild cervical abnormalities among HPV negative subjects

Full Information

First Posted
January 27, 2010
Last Updated
May 31, 2011
Sponsor
The University of Hong Kong
Collaborators
The Family Planning Association of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01058460
Brief Title
HPV-cytology Testing Versus Cytology Testing for the Detection of High Grade CIN
Acronym
COCY
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 Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
The University of Hong Kong
Collaborators
The Family Planning Association of Hong Kong

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Cervical Intraepithelial Neoplasia
Keywords
Cervical Intraepithelial Neoplasia, Grade III, Cervical Intraepithelial Neoplasia, Grade II

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
cytology
Arm Type
No Intervention
Arm Description
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.
Arm Title
HPV-cytology
Arm Type
Experimental
Arm Description
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 Type
Procedure
Intervention Name(s)
HPV-cytology co-testing
Intervention Description
Subjects will receive HPV testing and conventional cytology testing at baseline. Follow up management will be based on both results.
Primary Outcome Measure Information:
Title
Histological CIN2, CIN3 and cervical carcinoma
Time Frame
At baseline and each subsequent follow-up
Secondary Outcome Measure Information:
Title
Clearance of mild cervical abnormalities among HPV negative subjects
Time Frame
At baseline and 1-year after

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hextan YS Ngan, MD, MBBS
Phone
852-2255-4684
Email
hysngan@hkusua.hku.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hextan YS Ngan, MD, MBBS
Organizational Affiliation
Department of Obstetrics & Gynaecology, The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics & Gynaecology, The University of Hong Kong
City
Hong Kong SAR
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hextan YS Ngan, MD, MBBS

12. IPD Sharing Statement

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

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