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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


N/A
30 Years
60 Years
Open (Enrolling)
Female
Cervical Cancer, Cervical Intraepithelial Neoplasia

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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

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