UnknownNot Applicable

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

China12,000 participantsStarted 2010-06

Plain-language 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.

Who can participate

Age range30 Years – 60 Years

SexFEMALE

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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

What they're measuring

Histological CIN2, CIN3 and cervical carcinoma

Timeframe: At baseline and each subsequent follow-up

Trial details

NCT IDNCT01058460

SponsorThe University of Hong Kong

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-06

Contact for this trial

Hextan YS Ngan, MD, MBBS

852-2255-4684 hysngan@hkusua.hku.hk

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