Brief Title
HPV-cytology Testing Versus Cytology Testing for the Detection of High Grade CIN
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
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:
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 Type
Interventional
Primary Outcome
Histological CIN2, CIN3 and cervical carcinoma
Secondary Outcome
Clearance of mild cervical abnormalities among HPV negative subjects
Condition
Cervical Cancer
Intervention
HPV-cytology co-testing
Study Arms / Comparison Groups
cytology
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
12000
Start Date
June 2010
Completion Date
June 2017
Primary Completion Date
June 2017
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
Gender
Female
Ages
30 Years - 60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Hextan YS Ngan, MD, MBBS, 852-2255-4684, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT01058460
Organization ID
UW09-377
Study Sponsor
The University of Hong Kong
Collaborators
The Family Planning Association of Hong Kong
Study Sponsor
Hextan YS Ngan, MD, MBBS, Principal Investigator, Department of Obstetrics & Gynaecology, The University of Hong Kong
Verification Date
May 2011