HPV Integration Testing for Human Papillomavirus-Positive Women

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

• Registration Number: NCT02576262
• Lead Sponsor: Huazhong University of Science and Technology

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• 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: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HPV-positive women，30-65 years of age	TCT，HPV，colposcopic inspection	-

Primary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of the HPV integration screening test with comparison to HPV testing or TCT	14 Months

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China