Brief Title
HPV Integration Testing for Human Papillomavirus-Positive Women
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.
Study Type
Observational
Primary Outcome
Sensitivity and Specificity of the HPV integration screening test with comparison to HPV testing or TCT
Condition
Cervical Intraepithelial Neoplasia
Intervention
TCT,HPV,colposcopic inspection
Study Arms / Comparison Groups
HPV-positive women,30-65 years of age
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
1200
Start Date
September 2015
Completion Date
September 2020
Primary Completion Date
September 2018
Eligibility Criteria
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
Gender
Female
Ages
30 Years - 65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Ding Ma, MD, PhD, +862783662681, [email protected]
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT02576262
Organization ID
CCS-02
Responsible Party
Principal Investigator
Study Sponsor
Huazhong University of Science and Technology
Study Sponsor
Ding Ma, MD, PhD, Study Chair, Huazhong University of Science and Technology
Verification Date
June 2017