- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05290428
DNA PAX1 and JAM3 Methylation for Cervical Cancer Screening
March 12, 2022 updated by: Lei Li, Peking Union Medical College Hospital
The Accuracy of Host DNA PAX1 and JAM3 Methylation for Cervical Cancer Screening: a Multi-center, Double-blind, Parallel Controlled Clinical Trials
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
459
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lie Li, M.D.
- Phone Number: 10-139-1198-8831
- Email: lileigh@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100730
- Recruiting
- Lei Li
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
All participants will accept surgeries harvesting cervical histology.
Description
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
Exclusion Criteria:
- Not meeting all of the inclusion criteria
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Retrospective part
This part will enroll at least 120 cases in previously preserved samples.
|
All cervical cytology samples will be tested for PAX1 and JAM3 methylation
|
Prospective part
This part will enroll at least 339 cases.
|
All cervical cytology samples will be tested for PAX1 and JAM3 methylation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity of methylation testing
Time Frame: One week
|
Sensitivity of methylation testing of cervical cytology compared with histology
|
One week
|
Specificity of methylation testing
Time Frame: One week
|
Specificity of methylation testing of cervical cytology compared with histology
|
One week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Positive predictive value of methylation testing
Time Frame: One week
|
Positive predictive value of methylation testing of cervical cytology compared with histology
|
One week
|
Negative predictive value of methylation testing
Time Frame: One week
|
Negative predictive value of methylation testing of cervical cytology compared with histology
|
One week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 12, 2022
Primary Completion (ANTICIPATED)
September 12, 2022
Study Completion (ANTICIPATED)
December 12, 2022
Study Registration Dates
First Submitted
March 12, 2022
First Submitted That Met QC Criteria
March 12, 2022
First Posted (ACTUAL)
March 22, 2022
Study Record Updates
Last Update Posted (ACTUAL)
March 22, 2022
Last Update Submitted That Met QC Criteria
March 12, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- METHY4
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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University of California, San DiegoWithdrawnCervical Cancer | Cervical Cancer Stage | Cervical Cancer Stage IB2 | Cervical Cancer Stage IB1 | Cervical Cancer Stage I | Cervical Cancer Stage IB | Cervical Cancer Stage II | Cervical Cancer Stage IIa | Cervical Cancer, Stage IIB | Cervical Cancer, Stage III | Cervical Cancer Stage IIIB | Cervical Cancer... and other conditionsUnited States
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Abramson Cancer Center of the University of PennsylvaniaWithdrawnCervical Cancer | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer
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National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical CancerUnited States
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IA Cervical Cancer | Stage IB Cervical Cancer | Stage IA1 Cervical Cancer | Stage IA2 Cervical Cancer | Stage IB1 Cervical Cancer | Stage IB2 Cervical Cancer | Stage IB3 Cervical CancerUnited States
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Shanghai First Maternity and Infant HospitalNot yet recruitingCervical Cancer, Stage IIB | Cervical Cancer Stage IIIB | Cervical Cancer Stage IIIA | Cervical Cancer, Stage IVA
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University of Southern CaliforniaNational Cancer Institute (NCI)CompletedRecurrent Cervical Cancer | Stage IVA Cervical Cancer | Stage IVB Cervical Cancer | Stage IIIA Cervical Cancer | Stage IIIB Cervical CancerUnited States
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Gynecologic Oncology GroupNational Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Squamous Cell Carcinoma | Stage IB Cervical Cancer | Stage IIA Cervical Cancer | Stage IIB Cervical Cancer | Stage III Cervical Cancer | Stage IVA Cervical CancerUnited States
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Institut de Cancérologie de LorraineCompletedCervical Adenocarcinoma | Stage IB Cervical Cancer | Stage III Cervical Cancer | Stage II Cervical CancerFrance
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