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DNA Methylation for Screening Uterine Cervical Lesions

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ClinicalTrials.gov Identifier: NCT03960879
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Lei Li, Peking Union Medical College Hospital

Brief Summary:

The primary objective of this study is to compare the testing of DNA methylation, high-risk HPV subtypes, and cytology with the definite histological results for uterine cervical lesions in a prospective cohort study.

This study will include 300 unselected patients with definite histological results. All the cervical specimens of cytology collected in the clinical settings will be utilized for the testing of DNA methylation, high-risk HPV subtypes and thin prep liquid-based cytology test (TCT). The sensitivity, specificity, positive predictive value and negative predictive value were calculated based on the known histological results. The differences of DNA methylation with high-risk human papillomavirus (HPV) and TCT will also be analyzed.

The testing of DNA methylation will be performed with the methylation-specific polymerase chain reaction (PCR). The TCT and HPV testing will be performed with the Roche kits.


Condition or disease Intervention/treatment
DNA Methylation Uterine Cervical Cancer High Grade Squamous Intraepithelial Lesions Low Grade Squamous Intraepithelial Lesions Diagnostic Test: DNA methylation Diagnostic Test: High-risk HPV Diagnostic Test: TCT

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DNA Methylation Testing for the Screening of Uterine Cervical Lesion: A Prospective Cohort Study
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: DNA methylation
    DNA methylation for the cervical cytology
  • Diagnostic Test: High-risk HPV
    High-risk HPV testing for the cervical cytology
  • Diagnostic Test: TCT
    Thin prep liquid-based cytology test for the cervical cytology


Primary Outcome Measures :
  1. Sensitivity of DNA methylation [ Time Frame: 1 year ]
    Sensitivity of DNA methylation compared with histological results for the differentiation of cervical cancer and high grade squamous intraepithelial lesions (HSIL)

  2. Specificity of DNA methylation [ Time Frame: 1 year ]
    Specificity of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL


Secondary Outcome Measures :
  1. Positive predictive value of DNA methylation [ Time Frame: 1 year ]
    Positive predictive value of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL

  2. Negative predictive value of DNA methylation [ Time Frame: 1 year ]
    Negative predictive value of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL

  3. Correlation coefficient of DNA methylation with other screening methods [ Time Frame: 1 year ]
    Correlation coefficient of DNA methylation with high-risk HPV and TCT results


Biospecimen Retention:   Samples With DNA
Uterine cervical cytology collected during the clinical settings for the testing of DNA methylation, TCT and high-risk HPV


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  • Confirmed cervical histology within one month when collecting cervical cytology
  • Aged 18 years or older
Criteria

Inclusion Criteria:

  • Confirmed cervical histology within one month when collecting cervical cytology
  • Aged 18 years or older
  • Signed an approved informed consents

Exclusion Criteria:

  • Not meeting all of the inclusion criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03960879


Contacts
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Contact: Lei Li +8613911988831 lilei@163.com

Locations
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China, Beijing
Lei Li Recruiting
Beijing, Beijing, China, 100730
Contact: Lei Li, MD    008613911988831    lileigh@163.com   
Sponsors and Collaborators
Lei Li
Investigators
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Principal Investigator: Lei Li, M.D. Peking Union Medical College Hospital

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Responsible Party: Lei Li, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT03960879     History of Changes
Other Study ID Numbers: METHY2
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Squamous Intraepithelial Lesions of the Cervix
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Uterine Cervical Dysplasia
Precancerous Conditions