HPV Integration Testing for Human Papillomavirus-Positive Women

Huazhong University of Science and Technology1,200 enrolled

Overview

Papanicolaou (Pap) triage, with high specificity, has been recommended for primary Human papillomavirus (HPV) testing but is flawed by poor sensitivity and cytologist dependence. the investigators evaluated the potential role of HPV Integration detection in cervical exfoliated cells in HPV-positive women from a clinic-based population.

Study Type

OBSERVATIONAL

Enrollment

1,200

Conditions

Cervical Intraepithelial Neoplasia Cervical Cancer

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 visiting the gynecologic clinic of hospital 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)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Outcomes

Primary Outcomes

Sensitivity and Specificity of the HPV integration screening test 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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