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

NCT ID: NCT01058460

Last Updated: 2011-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2017-06-30

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:

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.

Detailed Description

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Conditions

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Cervical Cancer Cervical Intraepithelial Neoplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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cytology

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

HPV-cytology

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

Group Type EXPERIMENTAL

HPV-cytology co-testing

Intervention Type PROCEDURE

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

Interventions

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HPV-cytology co-testing

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

Intervention Type PROCEDURE

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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The Family Planning Association of Hong Kong

OTHER

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Department of Obstetrics & Gynaecology, The University of Hong Kong

Principal Investigators

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Hextan YS Ngan, MD, MBBS

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics & Gynaecology, The University of Hong Kong

Locations

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Department of Obstetrics & Gynaecology, The University of Hong Kong

Hong Kong SAR, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hextan YS Ngan, MD, MBBS

Role: CONTACT

852-2255-4684

Other Identifiers

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UW09-377

Identifier Type: -

Identifier Source: org_study_id

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