HPV-cytology Testing Versus Cytology Testing for the Detection of High Grade CIN

Cervical Cancer Clinical Trial

— COCY  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01058460
• Other study ID #: UW09-377
• Status: Recruiting
• Phase: N/A
• First received: January 27, 2010
• Last updated: May 31, 2011
• Start date: June 2010
• Est. completion date: June 2017

Study information

• Verified date: May 2011
• Source: The University of Hong Kong
• Contact: Hextan YS Ngan, MD, MBBS
• Phone: 852-2255-4684
• Email: hysngan[@]hkusua.hku.hk
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12000
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Cancer
• Cervical Intraepithelial Neoplasia
• Neoplasms
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Department of Obstetrics & Gynaecology, The University of Hong Kong	Hong Kong SAR

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	The Family Planning Association of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histological CIN2, CIN3 and cervical carcinoma		At baseline and each subsequent follow-up	No
Secondary	Clearance of mild cervical abnormalities among HPV negative subjects		At baseline and 1-year after	No