HPV Integration Testing for Human Papillomavirus-Positive Women

NCT ID: NCT02576262

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

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-30

Study Completion Date

2020-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cervical Intraepithelial Neoplasia Cervical Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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HPV-positive women,30-65 years of age

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 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
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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Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 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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Danhui Weng, MD

Role: primary

+862783662681

Other Identifiers

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CCS-02

Identifier Type: -

Identifier Source: org_study_id

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