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

The University of Hong Kong12,000 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

12,000

Conditions

Cervical Cancer Cervical Intraepithelial Neoplasia

Interventions

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Histological CIN2, CIN3 and cervical carcinoma

Time frame: At baseline and each subsequent follow-up

Secondary Outcomes

Clearance of mild cervical abnormalities among HPV negative subjects

Time frame: At baseline and 1-year after