HPV Integration Testing for Cervical Cancer Screening

• Conditions: Cervical Intraepithelial Neoplasia; Cervical Cancer
• Interventions: Procedure: TCT，HPV，colposcopic inspection

• Registration Number: NCT02576158
• Lead Sponsor: Huazhong University of Science and Technology

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-09-22
• Study First Submitted QC: 2015-10-12
• Study First Posted: 2015-10-15
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-24
• Last Update Posted: 2017-06-27
• Primary Completion: 2018-09
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 12000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects will be women, 30-65 years of age	TCT，HPV，colposcopic inspection	Patients who are at average risk of developing cervical intraepithelial neoplasia or cervical cancer who are eligible for cervical cancer screening will be asked to collect Cervical Exfoliated Cells sample for the HPV integration screening test and for the HPV testing and TCT. Subjects with HPV positive will undergo colposcopy within 90 days of enrollment.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Women's Hospital, School of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China