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HPV Integration Testing for Human Papillomavirus-Positive Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02576262
Recruitment Status : Recruiting
First Posted : October 15, 2015
Last Update Posted : June 27, 2017
Information provided by (Responsible Party):
Ding Ma, 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.

Condition or disease Intervention/treatment
Cervical Intraepithelial Neoplasia Cervical Cancer Procedure: TCT,HPV,colposcopic inspection

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Other
Time Perspective: Prospective
Study Start Date : September 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
HPV-positive women,30-65 years of age Procedure: TCT,HPV,colposcopic inspection

Primary Outcome Measures :
  1. Sensitivity and Specificity of the HPV integration screening test with comparison to HPV testing or TCT [ Time Frame: 14 Months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02576262

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Contact: Danhui Weng, MD, PhD +862783662681

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China, Hubei
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology Recruiting
Wuhan, Hubei, China, 430030
Contact: Danhui Weng, MD    +862783662681   
Sponsors and Collaborators
Huazhong University of Science and Technology
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Study Chair: Ding Ma, MD, PhD Huazhong University of Science and Technology
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Responsible Party: Ding Ma, Chief Physician, Huazhong University of Science and Technology Identifier: NCT02576262    
Other Study ID Numbers: CCS-02
First Posted: October 15, 2015    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Cervical Intraepithelial Neoplasia
Carcinoma in Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type