HPV Integration Testing for Cervical Cancer Screening

Huazhong University of Science and Technology

Status: Unknown

Conditions: Cervical Intraepithelial Neoplasia; Cervical Cancer

Treatments: Procedure: TCT，HPV，colposcopic inspection

Study type: Observational

Funder types: Other

Identifiers

NCT02576158

CCS-01

Details and patient eligibility

About

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.

Enrollment: 12,000 estimated patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

12,000 participants in 1 patient group

Subjects will be women, 30-65 years of age

Description:

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.

Treatment:

Procedure: TCT，HPV，colposcopic inspection