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

NCT05851079 | Unknown

• 1 other identifier: IRB-20210333-R
• Study Type: observational
• Target: 15,000
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Screening methods; Cervical Lesion; Sensitivity; Accuracy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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.

Diagnostic Test: TCT test; Diagnostic Test: Vaginoscopy; Diagnostic Test: High throughput HPV typing and integration detection methods; Diagnostic Test: Cobas HPV test

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.

Diagnostic Test: TCT test; Diagnostic Test: High throughput HPV typing and integration detection methods; Diagnostic Test: Cobas HPV test

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.

Diagnostic Test: TCT test; Diagnostic Test: Vaginoscopy; Diagnostic Test: High throughput HPV typing and integration detection methods; Diagnostic Test: Cobas HPV test

Interventions

TCT test DIAGNOSTIC_TEST

These tests were performed on cervical exfoliated cells.

1. Stratified experimental design; 2. Parallel experimental design; 3. Prospective cohort study design:

Vaginoscopy DIAGNOSTIC_TEST

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

1. Stratified experimental design; 3. Prospective cohort study design:

High throughput HPV typing and integration detection methods DIAGNOSTIC_TEST

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

1. Stratified experimental design; 2. Parallel experimental design; 3. Prospective cohort study design:

Cobas HPV test DIAGNOSTIC_TEST

To obtain HPV typing results.

1. Stratified experimental design; 2. Parallel experimental design; 3. Prospective cohort study design:

Eligibility Criteria

• Age: 25 Years - 70 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects were recruited in the general and hospital populations.

You may qualify if:

• First screening.
• History of sexual intercourse.

You may not qualify if:

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

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead
• Wuhan Central Hospital: collaborator
• Tongji Hospital: collaborator

Study Sites (1)

Women's hospital school of medicine zhejiang university

Hangzhou, Zhejiang, 310000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Cervical exfoliated cells；Cervical biopsy

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Hui Wang, PhD

  Women's Hospital School Of Medicine Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui Wang, PhD

CONTACT

0571-89998857; wang71hui@zju.deu.cn

Xiao Li, PhD

CONTACT

13958160137; 5198009@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 9, 2023
• Study Start: December 10, 2021
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)