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

The University of Hong Kong (HKU)

Status: Unknown

Conditions: Cervical Intraepithelial Neoplasia; Cervical Cancer

Treatments: Procedure: HPV-cytology co-testing

Study type: Interventional

Funder types: Other

Identifiers

NCT01058460

UW09-377

Details and patient eligibility

About

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.

Enrollment: 12,000 estimated patients

Sex: Female

Ages: 30 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

12,000 participants in 2 patient groups

cytology

No Intervention group

Description:

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.

HPV-cytology

Experimental group

Description:

Subjects in the HPV-cytology arm will receive HPV testing and cytology testing at baseline. Follow up management will be based on both results.

Treatment:

Procedure: HPV-cytology co-testing