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Role of Methylation Test Triage in HPV Positive Women

NCT06366516 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10000

Last updated 2024-04-16

No results posted yet for this study

Summary

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.

Conditions

  • Precancerous Cervical Lesion

Interventions

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.

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    collaborator OTHER

  • Chengdu Women's and Children's Central Hospital

    collaborator OTHER

  • Guangdong Women and Children Hospital

    collaborator OTHER

  • Second Hospital of Jilin University

    collaborator OTHER

  • First Affiliated Hospital of Xinjiang Medical University

    collaborator OTHER

  • Third Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • Obstetrics & Gynecology Hospital of Fudan University

    lead OTHER

Principal Investigators

  • Long Sui, Professor · Obstetrics & Gynecology Hospital of Fudan University

  • Lan Zhu, Professor · Peking Union Medical College Hospital

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2025-08-31
Completion
2026-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06366516 on ClinicalTrials.gov