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HPV Integration Testing for Cervical Cancer Screening

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02576158
Recruitment Status : Unknown
Verified June 2017 by Ding Ma, Huazhong University of Science and Technology.
Recruitment status was:  Recruiting
First Posted : October 15, 2015
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Ding Ma, Huazhong University of Science and Technology

Brief Summary:
The primary objective is to determine the sensitivity and specificity of the HPV Integration-based cervical screening for detection of high-grade cervical intraepithelial neoplasia (CIN), using colposcopic inspection as the reference method. Lesions will be confirmed as malignant or CIN by colposcopic inspection and histopathologic examination.

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

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Study Type : Observational
Estimated Enrollment : 12000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: HPV(Human Papillomavirus) Integration Testing for Cervical Cancer Screening
Study Start Date : April 2015
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Group/Cohort Intervention/treatment
Subjects will be women, 30-65 years of age
Patients who are at average risk of developing cervical intraepithelial neoplasia or cervical cancer who are eligible for cervical cancer screening will be asked to collect Cervical Exfoliated Cells sample for the HPV integration screening test and for the HPV testing and TCT. Subjects with HPV positive will undergo colposcopy within 90 days of enrollment.
Procedure: TCT,HPV,colposcopic inspection



Primary Outcome Measures :
  1. the sensitivity and specificity of the HPV Integration-based cervical screening for detection of high-grade cervical intraepithelial neoplasia (CIN)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
healthy women between the ages of 30 and 65 years
Criteria

Inclusion Criteria:

Women aged 30-65 years old Attending the China population-based organised cervical screening program

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 ClinicalTrials.gov identifier (NCT number): NCT02576158


Contacts
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Contact: Danhui Weng, MD, PhD +862783662681 weng.dh@gmail.com

Locations
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China, Zhejiang
Women's Hospital, School of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310006
Contact: Yuyan Mao, MD    13989816955    maoyy3@yahoo.com.cn   
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
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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
ClinicalTrials.gov Identifier: NCT02576158    
Other Study ID Numbers: CCS-01
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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Uterine Cervical Neoplasms
Cervical Intraepithelial Neoplasia
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type