HPV-cytology Testing Versus Cytology Testing for the Detection of High Grade CIN
COCY
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
1 other identifier
interventional
12,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2010
CompletedFirst Posted
Study publicly available on registry
January 28, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJune 1, 2011
May 1, 2011
7 years
January 27, 2010
May 31, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Histological CIN2, CIN3 and cervical carcinoma
At baseline and each subsequent follow-up
Secondary Outcomes (1)
Clearance of mild cervical abnormalities among HPV negative subjects
At baseline and 1-year after
Study Arms (2)
cytology
NO INTERVENTIONSubjects 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.
HPV-cytology
EXPERIMENTALSubjects in the HPV-cytology arm will receive HPV testing and cytology testing at baseline. Follow up management will be based on both results.
Interventions
Subjects will receive HPV testing and conventional cytology testing at baseline. Follow up management will be based on both results.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Obstetrics & Gynaecology, The University of Hong Kong
Hong Kong SAR, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hextan YS Ngan, MD, MBBS
Department of Obstetrics & Gynaecology, The University of Hong Kong
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 27, 2010
First Posted
January 28, 2010
Study Start
June 1, 2010
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
June 1, 2011
Record last verified: 2011-05