HPV Integration Testing for Cervical Cancer Screening

Huazhong University of Science and Technology12,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

12,000

Conditions

Cervical Cancer Cervical Intraepithelial Neoplasia

Interventions

TCT，HPV，colposcopic inspectionPROCEDURE

Eligibility

Sex: FEMALEMin age: 30 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Women's Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 14 Months

Central Contacts

Danhui Weng, MD, PhD

CONTACT

+862783662681 weng.dh@gmail.com

Data from ClinicalTrials.gov

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