Role of Methylation Test Triage in HPV Positive Women (MTTRIHPW)

April 13, 2024 updated by: Obstetrics & Gynecology Hospital of Fudan University

Clinical Validation of ASTN1, DLX1, ITGA4, RXFP3, SOX17, ZNF671 Methylation in HPV Positive Women: a Multi-center RCT From China

The pathological results were used as the gold standard in this study and the investigators analyze the diagnostic value of six gene methylation status (ASTN1 DLX1, ITGA4, RXFP3, SOX17, ZNF671) in triaging high-risk human papillomavirus infection. The sensitivity and specificity of methylation test and cytology in the diagnosis of high-grade cervical lesions are compared in order to providing new methods and basis in improving the accuracy of cervical cancer screening.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is divided into two phases, a baseline (cross-sectional) phase and a 1-year follow-up phase. Women who meet the clinical endpoint (i.e. histopathologically confirmed ≥CIN2 after baseline colposcopy/biopsy) are withdrawn from the study. Participants who do not meet the primary endpoint/treat at baseline will invited to participate in the follow-up phase of the trial. Participants included in the follow-up phase are underwent HPV, cytology, and methylation tests at 6 months and 1 year after baseline.Similar to the baseline phase,participants were referred to colposcopy/biopsy if any of the cytology and HPV tests result is positive.

Study Type

Interventional

Enrollment (Estimated)

10000

Phase

  • Not Applicable

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

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200011
        • Obstetrics and Gynecology Hospital of Fudan University
        • Contact:
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • aged 25~65 years undergoing cervical cancer screening
  • normal for cytology and positive for hrHPV
  • informed consent was obtained

Exclusion Criteria:

  • pregnant
  • with a known history of ablation or treatment with cervical excision within 12 months
  • hysterectomy
  • chemoradiotherapy
  • planning to participate or taking part in another cancer screening, treatment, or vaccination study
  • do not meet the inclusion criteria
  • give up the trial or naturally dropped out of the follow-up during the observation process
  • people who asked to withdraw

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

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Women aged 25-65 years with high-risk HPV infection.
Ten thousand women were recruited who aged 25-65 years and they are positive for high-risk HPV.
Diagnostic test: Methylation Test

Participants who aged 25-65 years with high-risk HPV infection are recruited.To start with,cervical exfoliated cells are collected, coded (according to the actual enrollment sequence), and stored in the pathology department where methylation testing is performed.In addition,patients will underwent colposcopy and biopsy.

Patients are followed up by cytology, high-risk HPV and methylation tests at 6 and 12 months after enrollment.Cervical conization and hysterectomy will be taken if necessary according to histopathological results. The clinical endpoint is reached when CIN2+ is confirmed by histopathological result.

Other Names:
  • Biopsy
  • Liquid-based Cytology Test
  • High-risk HPV test
  • Colposcopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The sensitivity and specificity of methylation test in detecting CIN2+.
Time Frame: From date of enrollment until the date of first documented CIN2+,assessed up to 12 months
The primary variable of methylation test are as follows:clinical sensitivity, clinical specificity, positive predictive value, negative predictive value, positive likelihood ratio, negative likelihood ratio, positive coincidence rate, and negative coincidence rate.
From date of enrollment until the date of first documented CIN2+,assessed up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
KAPPA value of methylation test.
Time Frame: From date of enrollment until the date of first documented CIN2+,assessed up to 12 months
KAPPA value is the secondary variable of methylation test which need to meet statistical criteria.
From date of enrollment until the date of first documented CIN2+,assessed up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Obstetrics & Gynecology Hospital of Fudan University

Collaborators

Peking Union Medical College Hospital
First Affiliated Hospital of Xinjiang Medical University
Chengdu Women's and Children's Central Hospital
Second Hospital of Jilin University
Guangdong Women and Children Hospital
Third Affiliated Hospital of Zhengzhou University

Investigators

  • Study Chair: Long Sui, Professor, Obstetrics & Gynecology Hospital of Fudan University
  • Study Chair: Lan Zhu, Professor, Peking Union Medical College Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

April 1, 2024

Primary Completion (Estimated)

August 1, 2025

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

March 27, 2024

First Submitted That Met QC Criteria

April 13, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 13, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FUOBGY2024-23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All collected data from participants will be shared，including age of patients, the results of cytological examination/high-risk HPV genotyping/methylation test/histopathological, colposcopy impression, and whether cervical conization or hysterectomy were performed before.

IPD Sharing Time Frame

Starting 6 months after publication

IPD Sharing Access Criteria

We will apply for a web address to upload all collected clinical data and trial results. The public can send email or request access to the web if any of them needed. After waiting for the principal investigator's consent, the data would be shared by browsing the website.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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