Cervical Intraepithelial Neoplasia Grade 2/3NCT05851079
Accurate Screening and Prevention of Cervical Lesions-- Development of Accurate Screening Methods for Cervical Lesions
An observational study of Cervical Intraepithelial Neoplasia Grade 2/3 and Cervical Lesion, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 25 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Intraepithelial Neoplasia Grade 2/3, Cervical Lesion
- What is being tested?
- TCT test, Vaginoscopy and High throughput HPV typing and integration detection methods
- How many people
- 15,000 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2021to 30 Nov 2024
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects were recruited in the general and hospital populations.
Who may be able to join
- First screening.
- History of sexual intercourse.
Who cannot join
- Previous CIN, cervical cancer or other cervical lesions;
- History of cervical treatment;
- Age <25, >70 years;
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Women's hospital school of medicine zhejiang university
Hangzhou, Zhejiang, 310000
Hui Wang, PhD, 057189998857, wang71hui@zju.deu.cn
About this study
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:
Read more
- 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.
Read the detailed 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.
- Being tested
- TCT test, Vaginoscopy, High throughput HPV typing and integration detection methods, Cobas HPV test
- Keywords
- Screening methods, Cervical Lesion, Sensitivity, Accuracy
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCT testDiagnostic test
These tests were performed on cervical exfoliated cells.
VaginoscopyDiagnostic test
To obtain the results of the patient's pathology report.
High throughput HPV typing and integration detection methodsDiagnostic test
This is screening for ≥ cervical intraepithelial tumors (CIN2 or CIN3).
Cobas HPV testDiagnostic test
To obtain HPV typing results.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Diagnostic Test: TCT test; Diagnostic Test: Vaginoscopy; Diagnostic Test: High throughput HPV typing and integration detection methods; Diagnostic Test: Cobas HPV test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start10 Dec 2021
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial Neoplasia Grade 2/3Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan Central Hospital, Tongji Hospital
- Responsible party
- Sponsor
- Investigators
- Hui Wang, PhD, Principal investigator, Women's Hospital School Of Medicine Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851079
- Sponsor's protocol ID
- IRB-20210333-R
- Status last verified
- May 2023
- First submitted
- 24 Apr 2023
- Last updated
- 9 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accurate Screening and Prevention of Cervical Lesions-- Development of Accurate Screening Methods for Cervical Lesions
- ClinicalTrials.gov ID
- NCT05851079
- Acronym / sponsor ID
- IRB-20210333-R
- Keywords
- Screening methods, Cervical Lesion, Sensitivity, Accuracy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Wuhan Central Hospital, Tongji Hospital
- Study start
- 10 Dec 2021 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1. Stratified experimental design | – | Diagnostic Test: TCT test, Diagnostic Test: Vaginoscopy, Diagnostic Test: High throughput HPV typing and integration detection methods, Diagnostic Test: Cobas HPV testRelying 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 | – | Diagnostic Test: TCT test, Diagnostic Test: High throughput HPV typing and integration detection methods, Diagnostic Test: Cobas HPV testA 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: | – | Diagnostic Test: TCT test, Diagnostic Test: Vaginoscopy, Diagnostic Test: High throughput HPV typing and integration detection methods, Diagnostic Test: Cobas HPV testBased 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. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects were recruited in the general and hospital populations.
Key inclusion criteria (2 listed)
- First screening.
- History of sexual intercourse.
Key exclusion criteria (4 listed)
- Previous CIN, cervical cancer or other cervical lesions;
- History of cervical treatment;
- Age <25, >70 years;
- Pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCT testThese tests were performed on cervical exfoliated cells. | Diagnostic test | 1. Stratified experimental design, 2. Parallel experimental design, 3. Prospective cohort study design: |
| VaginoscopyTo obtain the results of the patient's pathology report. | Diagnostic test | 1. Stratified experimental design, 3. Prospective cohort study design: |
| High throughput HPV typing and integration detection methodsThis is screening for ≥ cervical intraepithelial tumors (CIN2 or CIN3). | Diagnostic test | 1. Stratified experimental design, 2. Parallel experimental design, 3. Prospective cohort study design: |
| Cobas HPV testTo obtain HPV typing results. | Diagnostic test | 1. Stratified experimental design, 2. Parallel experimental design, 3. Prospective cohort study design: |
Primary outcome
the risk of cervical intraepithelial neoplasia(CIN) 2 or worse
Time frame: 3 years
Patients who meet the requirements for referral colposcopy were further examined for CIN2+ by pathology.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hui Wang, PhD principal investigator
Women's Hospital School Of Medicine Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Intraepithelial Neoplasia Grade 2/3 and Cervical Lesion, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hui Wang, PhD (0571-89998857, wang71hui@zju.deu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the risk of cervical intraepithelial neoplasia(CIN) 2 or worse (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.