HPV Integration Testing for Human Papillomavirus-Positive Women
June 24, 2017 updated by: Ding Ma, Huazhong University of Science and Technology
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 Overview
Status
Unknown
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
1200
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hubei
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Wuhan, Hubei, China, 430030
- Recruiting
- Tongji Hospital, Tongji Medical college, Huazhong University of Science and Technology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
participants who visited the gynecologic clinic of hospital for various gynecologic disorders and underwent primary HPV testing were prospectively recruited
Description
Inclusion Criteria:
Women aged 30-65 years old visiting the gynecologic clinic of hospital
Exclusion Criteria:
- Not providing informed consent
- previously confirmed CIN, cervical cancer, or other malignancies
- previous therapeutic procedure to cervix
- pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
HPV-positive women，30-65 years of age
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Sensitivity and Specificity of the HPV integration screening test with comparison to HPV testing or TCT
Time Frame: 14 Months
|
14 Months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Ding Ma, MD, PhD, Huazhong University of Science and Technology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Anticipated)
September 1, 2018
Study Completion (Anticipated)
September 1, 2020
Study Registration Dates
First Submitted
September 22, 2015
First Submitted That Met QC Criteria
October 12, 2015
First Posted (Estimate)
October 15, 2015
Study Record Updates
Last Update Posted (Actual)
June 27, 2017
Last Update Submitted That Met QC Criteria
June 24, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCS-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.