HPV-cytology Testing Versus Cytology Testing for the Detection of High Grade CIN (COCY)
|ClinicalTrials.gov Identifier: NCT01058460|
Recruitment Status : Unknown
Verified May 2011 by The University of Hong Kong.
Recruitment status was: Recruiting
First Posted : January 28, 2010
Last Update Posted : June 1, 2011
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
- 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.
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Cervical Intraepithelial Neoplasia||Procedure: HPV-cytology co-testing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12000 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
|Study Start Date :||June 2010|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||June 2017|
No Intervention: 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.
Subjects in the HPV-cytology arm will receive HPV testing and cytology testing at baseline. Follow up management will be based on both results.
Procedure: HPV-cytology co-testing
Subjects will receive HPV testing and conventional cytology testing at baseline. Follow up management will be based on both results.
- Histological CIN2, CIN3 and cervical carcinoma [ Time Frame: At baseline and each subsequent follow-up ]
- Clearance of mild cervical abnormalities among HPV negative subjects [ Time Frame: At baseline and 1-year after ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01058460
|Contact: Hextan YS Ngan, MD, MBBSfirstname.lastname@example.org|
|Department of Obstetrics & Gynaecology, The University of Hong Kong||Recruiting|
|Hong Kong SAR, China|
|Principal Investigator: Hextan YS Ngan, MD, MBBS|
|Principal Investigator:||Hextan YS Ngan, MD, MBBS||Department of Obstetrics & Gynaecology, The University of Hong Kong|