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NCT02576158 Clinical Trial

HPV Integration Testing for Cervical Cancer Screening

Cervical Cancer Clinical Trial

Official title:
HPV（Human Papillomavirus） Integration Testing for Cervical Cancer Screening

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02576158
Other study ID # CCS-01
Secondary ID
Status Recruiting
Phase N/A
First received September 22, 2015
Last updated June 24, 2017
Start date April 2015
Est. completion date April 2020

Study information
Verified date June 2017
Source Huazhong University of Science and Technology
Contact Danhui Weng, MD, PhD
Phone +862783662681
Email weng.dh@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary objective is to determine the sensitivity and specificity of the HPV Integration-based cervical screening for detection of high-grade cervical intraepithelial neoplasia (CIN), using colposcopic inspection as the reference method. Lesions will be confirmed as malignant or CIN by colposcopic inspection and histopathologic examination.

Recruitment information / eligibility
Status Recruiting
Enrollment 12000
Est. completion date April 2020
Est. primary completion date September 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 65 Years
Eligibility Inclusion Criteria:

Women aged 30-65 years old Attending the China population-based organised cervical screening program

Exclusion Criteria:

1. Not providing informed consent

2. previously confirmed CIN, cervical cancer, or other malignancies

3. previous therapeutic procedure to cervix

4. pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• TCT,HPV,colposcopic inspection

Locations
Country Name City State
China Women's Hospital, School of Medicine, Zhejiang University Hangzhou Zhejiang

Sponsors (1)
Lead Sponsor Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary the sensitivity and specificity of the HPV Integration-based cervical screening for detection of high-grade cervical intraepithelial neoplasia (CIN)with comparison to HPV testing or TCT 14 Months
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