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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01058460

Acronym

COCY

Enrollment

12000

Registered

2010-01-28

Start date

2010-06-30

Completion date

2017-06-30

Last updated

2011-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, Cervical Intraepithelial Neoplasia

Keywords

Cervical Intraepithelial Neoplasia, Grade III, Cervical Intraepithelial Neoplasia, Grade II

Brief 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.

Interventions

PROCEDUREHPV-cytology co-testing

Subjects will receive HPV testing and conventional cytology testing at baseline. Follow up management will be based on both results.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Histological CIN2, CIN3 and cervical carcinoma	At baseline and each subsequent follow-up

Secondary

Measure	Time frame
Clearance of mild cervical abnormalities among HPV negative subjects	At baseline and 1-year after

Countries

China

Contacts

Primary ContactHextan YS Ngan, MD, MBBS

hysngan@hkusua.hku.hk852-2255-4684

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026