DNA Methylation for Screening Uterine Cervical Lesions: A Case-control Study

• Sponsor: Lei Li (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03961191
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 24.9

Study Details

Study Description

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 in a case-control study, so as to determine the accuracy of DNA methylation in the screening of uterine cervical lesions.

This study will include 300 patients with definite histological results, with 100 of cervical inflammation or low grade squamous intraepithelial lesions (LSIL), 100 of high grade squamous intraepithelial lesions (HSIL), and 100 of uterine cervical cancer. 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	Phase
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

Study Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Utilization of DNA Methylation in the Screening of Uterine Cervical Lesions: A Case-control Study
• Actual Study Start Date: May 22, 2019
• Anticipated Primary Completion Date: May 22, 2020
• Anticipated Study Completion Date: May 22, 2020

Arms and Interventions

Arm	Intervention/Treatment
Benign group Patients with benign cervical histology, including normal findings, inflammation and LSIL	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
HSIL group Patients with cervical histology of HSIL	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
Cancer group Patients with cervical histology of cancer	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

Outcome Measures

Primary Outcome Measures

1. Sensitivity of DNA methylation [1 years]

   Sensitivity of DNA methylation compared with histological results for the differentiation of cervical cancer and HSIL

2. Specificity of DNA methylation [1 years]

   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 [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 [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 [1 year]

   Correlation coefficient of DNA methylation with high-risk HPV and TCT results

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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 any of the inclusion criteria

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lei Li	Beijing	Beijing	China	100730

Sponsors and Collaborators

• Lei Li

Investigators

• Principal Investigator: Lei Li, M.D., Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lei Li, Professor, Peking Union Medical College Hospital
• ClinicalTrials.gov Identifier: NCT03961191
• Other Study ID Numbers: METHY1
• First Posted: May 23, 2019
• Last Update Posted: May 23, 2019
• Last Verified: May 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Uterine Cervical Neoplasms; Squamous Intraepithelial Lesions of the Cervix

Study Results

No Results Posted as of May 23, 2019