HPV Integration Testing for Cervical Cancer Screening

NCT ID: NCT02576158

Last Updated: 2017-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

12000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2020-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cervical Cancer Cervical Intraepithelial Neoplasia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

TCT,HPV,colposcopic inspection

Intervention Type PROCEDURE

Interventions

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TCT,HPV,colposcopic inspection

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Ding Ma

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ding Ma, MD, PhD

Role: STUDY_CHAIR

Huazhong University of Science and Technology

Locations

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Women's Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Danhui Weng, MD, PhD

Role: CONTACT

+862783662681

Facility Contacts

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Yuyan Mao, MD

Role: primary

13989816955

Other Identifiers

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CCS-01

Identifier Type: -

Identifier Source: org_study_id

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