HPV Integration Testing for Human Papillomavirus-Positive Women

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

NCT02576262

CCS-02

Details and patient eligibility

About

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.

Enrollment: 1,200 estimated patients

Sex: Female

Ages: 30 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,200 participants in 1 patient group

HPV-positive women，30-65 years of age

Treatment:

Procedure: TCT，HPV，colposcopic inspection