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HPV-cytology Testing Versus Cytology Testing for the Detection of High Grade CIN
Conditions
Cervical Cancer - Cervical Intraepithelial Neoplasia
Conditions: official terms
Carcinoma in Situ - Cervical Intraepithelial Neoplasia - Neoplasms - Uterine Cervical Neoplasms
Conditions: Keywords
Cervical Intraepithelial Neoplasia, Grade III, Cervical Intraepithelial Neoplasia, Grade II
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Intervention
Name: HPV-cytology co-testing
Type: Procedure
Overall Status
Recruiting
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.
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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: 60 Years
Minimum Age: 30 Years
Gender: Female
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
- 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
Location
Department of Obstetrics & Gynaecology, The University of Hong Kong
Hong Kong SAR, China
Status: Recruiting
Start Date
June 2010
Completion Date
June 2017
Sponsors
The University of Hong Kong
Source
The University of Hong Kong
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page