HPV-cytology Testing Versus Cytology Testing for the Detection of High Grade CIN
NCT ID: NCT01058460
Last Updated: 2011-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
12000 participants
INTERVENTIONAL
2010-06-30
2017-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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.
No interventions assigned to this group
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.
HPV-cytology co-testing
Subjects will receive HPV testing and conventional cytology testing at baseline. Follow up management will be based on both results.
Interventions
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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 Criteria
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Inclusion Criteria
* Women who have not attended screening for the past 3 years or more will be given priority
Exclusion Criteria
* 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
30 Years
60 Years
FEMALE
Yes
Sponsors
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The Family Planning Association of Hong Kong
OTHER
The University of Hong Kong
OTHER
Responsible Party
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Department of Obstetrics & Gynaecology, The University of Hong Kong
Principal Investigators
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Hextan YS Ngan, MD, MBBS
Role: PRINCIPAL_INVESTIGATOR
Department of Obstetrics & Gynaecology, The University of Hong Kong
Locations
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Department of Obstetrics & Gynaecology, The University of Hong Kong
Hong Kong SAR, , China
Countries
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Central Contacts
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Other Identifiers
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UW09-377
Identifier Type: -
Identifier Source: org_study_id
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