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

Study Overview
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Brief Summary
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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: 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.

Official Title
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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

Conditions
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Cervical Cancer, Cervical Intraepithelial Neoplasia

Intervention / Treatment
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* Procedure: HPV-cytology co-testing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: cytology<br>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. | |
| Experimental: HPV-cytology<br>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<br>* Subjects will receive HPV testing and conventional cytology testing at baseline. Follow up management will be based on both results.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological CIN2, CIN3 and cervical carcinoma |  | At baseline and each subsequent follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance of mild cervical abnormalities among HPV negative subjects |  | At baseline and 1-year after | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical Intraepithelial Neoplasia, Grade III, Cervical Intraepithelial Neoplasia, Grade II