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NCT02576262 Clinical Trial

HPV Integration Testing for Human Papillomavirus-Positive Women

Cervical Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02576262
Other study ID # CCS-02
Secondary ID
Status Recruiting
Phase N/A
First received September 22, 2015
Last updated June 24, 2017
Start date September 2015
Est. completion date September 2020

Study information
Verified date June 2017
Source Huazhong University of Science and Technology
Contact Danhui Weng, MD, PhD
Phone +862783662681
Email weng.dh@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1200
Est. completion date September 2020
Est. primary completion date September 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 30 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• TCT,HPV,colposcopic inspection

Locations
Country Name City State
China Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Wuhan Hubei

Sponsors (1)
Lead Sponsor Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity and Specificity of the HPV integration screening test with comparison to HPV testing or TCT 14 Months
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