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

Cervical Intraepithelial Neoplasia Grade 2/3 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05851079
• Other study ID #: IRB-20210333-R
• Status: Recruiting
• Start date: December 10, 2021
• Est. completion date: November 30, 2024

Study information

• Verified date: May 2023
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: Hui Wang, PhD
• Phone: 0571-89998857
• Email: wang71hui[@]zju.deu.cn
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

1. 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.

2. 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.

3. 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:

1. .Stratified study design subjects were selected from patients who were first screened for cervical cancer in hospital outpatient clinics.

2. .Parallel trial design subjects were selected from resident female residents in a cohort of cervical cancer screening established by a clinical center.

3. .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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15000
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

1. First screening.

2. History of sexual intercourse.

Exclusion Criteria:

1. Previous CIN, cervical cancer or other cervical lesions;

2. History of cervical treatment;

3. Age <25, >70 years;

4. Pregnancy.

Related Conditions & MeSH terms

• Cervical Intraepithelial Neoplasia
• Cervical Intraepithelial Neoplasia Grade 2/3
• Cervical Lesion
• Uterine Cervical Diseases

Intervention

Diagnostic Test:
• TCT test
These tests were performed on cervical exfoliated cells.
• Vaginoscopy
To obtain the results of the patient's pathology report.
• High throughput HPV typing and integration detection methods
This is screening for = cervical intraepithelial tumors (CIN2 or CIN3).
• Cobas HPV test
To obtain HPV typing results.

Locations

Country	Name	City	State
China	Women's hospital school of medicine zhejiang university	Hangzhou	Zhejiang

Sponsors (3)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University	Tongji Hospital, Wuhan Central Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the risk of cervical intraepithelial neoplasia(CIN) 2 or worse	Patients who meet the requirements for referral colposcopy were further examined for CIN2+ by pathology.	3 years