Clinical Evaluation of HPV Integration Triage for Detection of Cervical Precancer in HPV-positive Women

NCT ID: NCT05570331

Last Updated: 2022-10-06

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

RECRUITING

Total Enrollment

2200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2025-12-31

Brief Summary

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The American Society for Colposcopy and Cervical Pathology (ASCCP) recommended HPV testing or co-cytology testing as the standard primary approach for cervical cancer (CC) screening, which is highly sensitive for detection of cervical intraepithelial neoplasia grade 3 or worse. However, in clinical CC screening practice, the specificity and positive predictive value of the ASCCP-recommended strategy is relatively low, which leads to excessive colposcopy and common overtreatment, especially in China with a large number of cervical cancer cases. HPV integration in the host genome is a critical step in cervical carcinogenesis and is highly specific for detection of cervical cancer. Whether HPV integration analysis can play a role in the triage of cervical cancer screening has not yet been investigated.

Detailed Description

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Based on the dilemma of the cervical cancer screening process, in the last five years, our team developed a novel cervical cancer triage strategy and conducted a large cohort study, which evaluated the clinical performance of HPV integration triage alone and in combination with HPV16/18 or HPV16 genotyping of HPV-positive women. We found that the specificity of HPV integration for greater than cervical intraepithelial neoplasia 3 was 94.5%, which was significantly higher than that of cytology (63.8%; P \< 0.001) in our previous retrospective study.Here, we conducted a large prospective cohort study evaluating the clinical performance of HPV integration triage of HPV-positive women.

Conditions

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HPV Infection Cervical Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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HPV integration test

HPV-positive patients 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Consenting women aged 20y-70y with HPV-positive results

Exclusion Criteria

* Not providing informed consent
* previously confirmed CIN, cervical cancer, or other malignancies
* previous therapeutic procedure to cervix
* pregnancy
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ding Ma

OTHER

Sponsor Role lead

Responsible Party

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Ding Ma

Chairman of Obstetrics & Gynecology department of Tongji hospital

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ding Ma, MD, PhD

Role: STUDY_CHAIR

Tongji Hospital

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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Ting Hu, MD, PhD

Role: CONTACT

862783662681

Facility Contacts

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Ting Hu, MD,PhD

Role: primary

+862783662681

Other Identifiers

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TJ-IRB20220142

Identifier Type: -

Identifier Source: org_study_id

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