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

Women's Hospital School Of Medicine Zhejiang University

Status

Enrolling

Conditions

Cervical Lesion

Cervical Intraepithelial Neoplasia Grade 2/3

Treatments

Diagnostic Test: TCT test

Diagnostic Test: High throughput HPV typing and integration detection methods

Diagnostic Test: Vaginoscopy

Diagnostic Test: Cobas HPV test

Study type

Observational

Funder types

Other

Identifiers

NCT05851079

IRB-20210333-R

Details and patient eligibility

About

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.

Full description

Stratified experimental design:

Relying on the project's clinical multicenter to recruit patients for routine HPV screening in hospital outpatient clinics, for HPV high-risk type-positive subjects. The subjects with positive HPV types will continue to undergo TCT and colposcopic biopsy, and the remaining specimens after routine screening will be collected for high-throughput HPV typing and integrated assays. The sensitivity and accuracy of high-throughput HPV typing and integrated assays were compared with conventional screening methods.
Parallel experimental design:

A multicenter cohort of 12,000 permanent residents was recruited for routine cervical cancer screening(HPV+TCT combined screening), and the remaining specimens were collected after the conventional screening to test the indexes of high-throughput HPV typing and integrated assays. The sensitivity and accuracy of high-throughput HPV typing and integrated assays were compared with conventional screening methods.
Prospective cohort study design:

Based on a multicenter cohort of cervical cancer screening based on the project group, 3000 cervical cancer patients with HPV-positive routine screening and colposcopic biopsies were enrolled. The cohort was followed up regularly for 3 years with routine HPV+TCT and colposcopy, and cervical biopsy if necessary. And specimens remaining after routine screening will be collected for testing of high-throughput HPV typing and integrated assays.

4.subject selection:

.Stratified study design subjects were selected from patients who were first screened for cervical cancer in hospital outpatient clinics.
.Parallel trial design subjects were selected from resident female residents in a cohort of cervical cancer screening established by a clinical center.
.The prospective cohort study was designed to include HPV-positive patients in the cohort of cervical cancer screening established by the clinical center and whose cervical lesions were excluded by colposcopic biopsy.

5.This project is a multicenter prospective cohort study to investigate the immediate, 1st year, 2nd year and 3rd year cumulative risk of developing CIN2+ and CIN3+ in HPV 16 or 18-positive patients with positive and negative test results by integrating test results through a logistic Weibull model to assess whether colposcopy can be delayed and thus serve as a cervical cancer screening triage by comparing with risk values and clinical thresholds in the 2019 American Society for Colposcopy and Cervical Pathology(ASCCP)guidelines.

Enrollment

15,000 estimated patients

Sex

Female

Ages

25 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

First screening.
History of sexual intercourse.

Exclusion criteria

Previous CIN, cervical cancer or other cervical lesions;
History of cervical treatment;
Age <25, >70 years;
Pregnancy.

Trial design

15,000 participants in 3 patient groups

1. Stratified experimental design

Description:

Relying on the project's clinical multicenter to recruit patients for routine HPV screening in hospital outpatient clinics, for HPV high-risk type-positive subjects. The subjects with positive HPV types will continue to undergo TCT and colposcopic biopsy, and the remaining specimens after routine screening will be collected for high-throughput HPV typing and integrated assays. The sensitivity and accuracy of high-throughput HPV typing and integrated assays were compared with conventional screening methods.

Treatment:

Diagnostic Test: Vaginoscopy

Diagnostic Test: Cobas HPV test

Diagnostic Test: TCT test

Diagnostic Test: High throughput HPV typing and integration detection methods

2. Parallel experimental design

Description:

A multicenter cohort of 12,000 permanent residents was recruited for routine cervical cancer screening(HPV+TCT combined screening), and the remaining specimens were collected after the conventional screening to test the indexes of high-throughput HPV typing and integrated assays. The sensitivity and accuracy of high-throughput HPV typing and integrated assays were compared with conventional screening methods.

Treatment:

Diagnostic Test: Cobas HPV test

Diagnostic Test: TCT test

Diagnostic Test: High throughput HPV typing and integration detection methods

3. Prospective cohort study design:

Description:

Treatment:

Diagnostic Test: Vaginoscopy

Diagnostic Test: Cobas HPV test

Diagnostic Test: TCT test

Diagnostic Test: High throughput HPV typing and integration detection methods