DNA PAX1 and JAM3 Methylation for Cervical Cancer Screening

NCT ID: NCT05290428

Last Updated: 2022-03-22

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

459 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-12

Study Completion Date

2022-12-12

Brief Summary

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Based on the previous study of NCT03961191 and NCT03960879, we performed this trial to further confirm the accuracy of host DNA PAX1 and JAM3 methylation for cervical cancer screening. This study would provide profound basis for the approval of assay kit of DNA methylation in China for cervical screening. Three hospitals, including Peking Union Medical College Hospital, would enroll eligible patients in this study. The cervical cytology of 3 ml will be collected for the detection of DNA PAX1 and JAM3 methylation, and the results will compared with the cervical histological pathology, which is achieved after collection of cervical cytology, by surgeries including loop electrosurgical excision procedure, cervical conization, total hysterectomy and others. The methylation testing would be double-blinded in operators and analysts. The retrospective and prospective parts will enroll at least 120 patients and at least 339 patients, respectively.

Detailed Description

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Conditions

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Cervical Cancer Cervical Intraepithelial Neoplasia DNA Methylation Cancer Screening Detection Accuracy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Retrospective part

This part will enroll at least 120 cases in previously preserved samples.

DNA methylation testing

Intervention Type DIAGNOSTIC_TEST

All cervical cytology samples will be tested for PAX1 and JAM3 methylation

Prospective part

This part will enroll at least 339 cases.

DNA methylation testing

Intervention Type DIAGNOSTIC_TEST

All cervical cytology samples will be tested for PAX1 and JAM3 methylation

Interventions

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DNA methylation testing

All cervical cytology samples will be tested for PAX1 and JAM3 methylation

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* With uterine cervix intact
* Aged 18 years or older
* With accessible histological results of cervix
* Signed an approved informed consents
* With accessible cervical cytology before harvesting cervical histology
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Zhejiang Provincial People's Hospital

OTHER

Sponsor Role collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lei Li

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lei Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Lei Li

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Lie Li, M.D.

Role: CONTACT

10-139-1198-8831

Facility Contacts

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Lei Li, MD

Role: primary

8613911988831

Other Identifiers

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METHY4

Identifier Type: -

Identifier Source: org_study_id

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