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

Conditions

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

  • China
    • Hubei
      • 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:

  1. Not providing informed consent
  2. previously confirmed CIN, cervical cancer, or other malignancies
  3. previous therapeutic procedure to cervix
  4. 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
Procedure: TCT，HPV，colposcopic inspection

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.

Sponsor

Huazhong University of Science and Technology

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.

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