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Accurate Screening and Prevention of Cervical Lesions-- Development of Accurate Screening Methods for Cervical Lesions

NCT05851079 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 15000

Last updated 2023-05-09

No results posted yet for this study

Summary

The goal of this observational study is to compare the accuracy and sensitivity of High-throughput human papilloma virus(HPV) typing and integrated assays with routine screening protocols (Cobas HPV test combined with thinprep cytologic test(TCT) for the detection of cervical intraepithelial neoplasia in the general and hospital populations.

The main questions it aims to answer are:

* High-throughput HPV typing and integrated assays can screen for ≥ cervical intraepithelial neoplasia (CIN2 or CIN3) with high sensitivity and accuracy.
* High-throughput HPV typing and integrated assays can be promoted as a screening tool for cervical cancer.

Participants will be screened with routine screening protocols (Cobas HPV test combined with TCT test), and if the results are abnormal, colposcopy and cervical biopsy will be performed.

Conditions

  • Cervical Intraepithelial Neoplasia Grade 2/3
  • Cervical Lesion

Interventions

DIAGNOSTIC_TEST

TCT test

These tests were performed on cervical exfoliated cells.

DIAGNOSTIC_TEST

Vaginoscopy

To obtain the results of the patient's pathology report.

DIAGNOSTIC_TEST

High throughput HPV typing and integration detection methods

This is screening for ≥ cervical intraepithelial tumors (CIN2 or CIN3).

DIAGNOSTIC_TEST

Cobas HPV test

To obtain HPV typing results.

Sponsors & Collaborators

  • Wuhan Central Hospital

    collaborator OTHER

  • Tongji Hospital

    collaborator OTHER

  • Women's Hospital School Of Medicine Zhejiang University

    lead OTHER

Principal Investigators

  • Hui Wang, PhD · Women's Hospital School Of Medicine Zhejiang University

Eligibility

Min Age
25 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-12-10
Primary Completion
2024-11-30
Completion
2024-11-30

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 NCT05851079 on ClinicalTrials.gov