Clinical trial NCT05851079: Accurate Screening and Prevention of Cervical Lesions-- Development of Accurate Screening Methods for Cervical Lesions
Official title: Accurate Screening and Prevention of Cervical Lesions-- Development of Accurate Screening Methods for Cervical Lesions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Intraepithelial Neoplasia Grade 2/3
Cervical Lesion
Keywords: Screening methods
Cervical Lesion
Sensitivity
Accuracy
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
Collaborators: name: Wuhan Central Hospital
name: Tongji Hospital
First posted: 2023-05-09
Enrollment: 15000
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects were recruited in the general and hospital populations.

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.

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.

Eligibility 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.

Primary outcomes:
measure: the risk of cervical intraepithelial neoplasia(CIN) 2 or worse
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Women's hospital school of medicine zhejiang university
state: Zhejiang
Study officials:
affiliation: Women's Hospital School Of Medicine Zhejiang University
name: Hui Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: