Trial Information
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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Outcome Measure:
Histological CIN2, CIN3 and cervical carcinoma
Outcome Time Frame:
At baseline and each subsequent follow-up
Safety Issue:
No
Principal Investigator
Hextan YS Ngan, MD, MBBS
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Obstetrics & Gynaecology, The University of Hong Kong
Authority:
Hong Kong: Ethics Committee
Study ID:
UW09-377
NCT ID:
NCT01058460
Start Date:
June 2010
Completion Date:
June 2017
Related Keywords:
- Cervical Cancer
- Cervical Intraepithelial Neoplasia
- Cervical Intraepithelial Neoplasia, Grade III
- Cervical Intraepithelial Neoplasia, Grade II
- Neoplasms
- Uterine Cervical Neoplasms
- Cervical Intraepithelial Neoplasia
- Carcinoma in Situ