The Predictive Role of HPV Integration in HSIL and Cervical Cancer

NCT ID: NCT05300243

Last Updated: 2022-03-29

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

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-07

Study Completion Date

2022-06-01

Brief Summary

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The stratified analysis by the level of HPV DNA integration in HSIL and cervical cancer will be drawn to explore whether the status of HPV integration makes any difference in the progression of cervical cancer. The purpose of the research is to reduce the miss of cervix lesions and prove that HPV integration detection is sensitive in cervical cancer precise screening.

Detailed Description

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Conditions

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HPV Integration

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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HPV integration test

The stratified analysis by the level of HPV DNA integration in HSIL and cervical cancer will be drawn to explore whether the status of HPV integration makes any difference in the progression of cervical cancer. The purpose of the research is to reduce the miss of cervix lesions and prove that HPV integration detection is sensitive in cervical cancer precise screening.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* HPV-positive patients; Patients have completed HPV detection, TCT, and HPV integration detection before surgery or biopsy; Patients with priced diagnoses accepted treatment according to ASCCP Risk-Based Management Consensus Guidelines for Abnormal Cervical Cancer Screening Tests and Cancer Precursors; Patients who are voluntary participants in this research and cooperate to follow-up with subscribing informed consent.

Exclusion Criteria

* Patients who are not suitable for the trial; Patients existing other subtype malignancy tumors are still in treatment.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shuang Li

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shuang Li, PHD

Role: CONTACT

+86 18971625668

Facility Contacts

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Shuang Li

Role: primary

+8618971625668

Other Identifiers

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2021-S140

Identifier Type: -

Identifier Source: org_study_id

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