NCT03961191

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

May 22, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 23, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2020

Completed
Last Updated

May 23, 2019

Status Verified

May 1, 2019

Enrollment Period

1 year

First QC Date

May 21, 2019

Last Update Submit

May 22, 2019

Conditions

DNA MethylationUterine Cervical CancerHigh Grade Squamous Intraepithelial LesionsLow Grade Squamous Intraepithelial Lesions

Outcome Measures

Primary Outcomes (2)

  • Sensitivity of DNA methylation

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

    1 years

  • Specificity of DNA methylation

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

    1 years

Secondary Outcomes (3)

  • Positive predictive value of DNA methylation

    1 year

  • Negative predictive value of DNA methylation

    1 year

  • Correlation coefficient of DNA methylation with other screening methods

    1 year

Study Arms (3)

Benign group

Patients with benign cervical histology, including normal findings, inflammation and LSIL

Diagnostic Test: DNA methylationDiagnostic Test: high-risk HPVDiagnostic Test: TCT

HSIL group

Patients with cervical histology of HSIL

Diagnostic Test: DNA methylationDiagnostic Test: high-risk HPVDiagnostic Test: TCT

Cancer group

Patients with cervical histology of cancer

Diagnostic Test: DNA methylationDiagnostic Test: high-risk HPVDiagnostic Test: TCT

Interventions

DNA methylationDIAGNOSTIC_TEST

DNA methylation for the cervical cytology

Benign groupCancer groupHSIL group
high-risk HPVDIAGNOSTIC_TEST

High-risk HPV testing for the cervical cytology

Benign groupCancer groupHSIL group
TCTDIAGNOSTIC_TEST

Thin prep liquid-based cytology test for the cervical cytology

Benign groupCancer groupHSIL group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

1. Wtih confirmed cervical histology within one month when collecting cervical cytology 2. Aged 18 years or older

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lei Li

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical NeoplasmsSquamous Intraepithelial Lesions

Interventions

DNA Methylation

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesMorphological and Microscopic FindingsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethylationAlkylationBiochemical PhenomenaChemical PhenomenaMetabolismGenetic Phenomena

Study Officials

  • Lei Li, M.D.

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Li, M.D.

CONTACT

+8613911988831lileigh@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 21, 2019

First Posted

May 23, 2019

Study Start

May 22, 2019

Primary Completion

May 22, 2020

Study Completion

May 22, 2020

Last Updated

May 23, 2019

Record last verified: 2019-05

Locations

CN(1)