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Trial Title:
Accurate Screening and Prevention of Cervical Lesions-- Development of Accurate Screening Methods for Cervical Lesions
NCT ID:
NCT05851079
Condition:
Cervical Intraepithelial Neoplasia Grade 2/3
Cervical Lesion
Conditions: Official terms:
Uterine Cervical Dysplasia
Uterine Cervical Diseases
Conditions: Keywords:
Screening methods
Cervical Lesion
Sensitivity
Accuracy
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
TCT test
Description:
These tests were performed on cervical exfoliated cells.
Arm group label:
1. Stratified experimental design
Arm group label:
2. Parallel experimental design
Arm group label:
3. Prospective cohort study design:
Intervention type:
Diagnostic Test
Intervention name:
Vaginoscopy
Description:
To obtain the results of the patient's pathology report.
Arm group label:
1. Stratified experimental design
Arm group label:
3. Prospective cohort study design:
Intervention type:
Diagnostic Test
Intervention name:
High throughput HPV typing and integration detection methods
Description:
This is screening for ≥ cervical intraepithelial tumors (CIN2 or CIN3).
Arm group label:
1. Stratified experimental design
Arm group label:
2. Parallel experimental design
Arm group label:
3. Prospective cohort study design:
Intervention type:
Diagnostic Test
Intervention name:
Cobas HPV test
Description:
To obtain HPV typing results.
Arm group label:
1. Stratified experimental design
Arm group label:
2. Parallel experimental design
Arm group label:
3. Prospective cohort study design:
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.
Detailed 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.
Criteria for eligibility:
Study pop:
Subjects were recruited in the general and hospital populations.
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
Female
Gender based:
Yes
Gender description:
Female
Minimum age:
25 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Women's hospital school of medicine zhejiang university
Address:
City:
Hangzhou
Zip:
310000
Country:
China
Status:
Recruiting
Contact:
Last name:
Hui Wang, PhD
Phone:
057189998857
Email:
wang71hui@zju.deu.cn
Start date:
December 10, 2021
Completion date:
November 30, 2024
Lead sponsor:
Agency:
Women's Hospital School Of Medicine Zhejiang University
Agency class:
Other
Collaborator:
Agency:
Wuhan Central Hospital
Agency class:
Other
Collaborator:
Agency:
Tongji Hospital
Agency class:
Other
Source:
Women's Hospital School Of Medicine Zhejiang University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05851079
