To hear about similar clinical trials, please enter your email below
Trial Title:
HPV-cytology Testing Versus Cytology Testing for the Detection of High Grade CIN
NCT ID:
NCT01058460
Condition:
Cervical Cancer
Cervical Intraepithelial Neoplasia
Conditions: Official terms:
Uterine Cervical Neoplasms
Neoplasms
Carcinoma in Situ
Uterine Cervical Dysplasia
Conditions: Keywords:
Cervical Intraepithelial Neoplasia, Grade III
Cervical Intraepithelial Neoplasia, Grade II
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Procedure
Intervention name:
HPV-cytology co-testing
Description:
Subjects will receive HPV testing and conventional cytology testing at baseline. Follow
up management will be based on both results.
Arm group label:
HPV-cytology
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.
Criteria for 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
Minimum age:
30 Years
Maximum age:
60 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Department of Obstetrics & Gynaecology, The University of Hong Kong
Address:
City:
Hong Kong SAR
Country:
China
Status:
Recruiting
Investigator:
Last name:
Hextan YS Ngan, MD, MBBS
Email:
Principal Investigator
Start date:
June 2010
Completion date:
June 2017
Lead sponsor:
Agency:
The University of Hong Kong
Agency class:
Other
Collaborator:
Agency:
The Family Planning Association of Hong Kong
Agency class:
Other
Source:
The University of Hong Kong
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01058460
