Primary Cervical Cancer Screening by Self-sampling HPV Test (PREVENT)

December 19, 2023 updated by: Wang Jianliu, Peking University People's Hospital
Cervical cancer seriously threatens women's health and HPV infection is the main cause of cervical cancer. Traditionally, Cervical cancer screening is based on cervical exfoliated cell samples collected by health care provider, which is labor consuming and the coverage and compliance are both relatively low in some areas. Non-invasive hrHPV self-sampling test appears to be more acceptable and may improve the HPV screening coverage. This study aims to evaluate the clinical performance of a newly developed urine/vaginal self-sampling hrHPV test in Cervical cancer screening.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

This study is a prospective multi-center clinical trial in China. Eligible participants are cervical cancer screening population who meet the enrollment criterias. All the participants are required to provide urine and vaginal samples by self-sampling, as well as the cervical exfoliated cell samples (by HCP). Participants may undergo colposcopy examination depending on the test results, and they will be followed up for three years.

The high-risk human papillomavirus nucleic acid detection kit (PCR-fluorescent probe method) developed by New Horizon Co., Ltd . is suitable for in vitro qualitative detection of 14 types of high-risk HPV ( 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) nucleic acid.

The clinical performance of the self-sampling test will be assessed base on the following outcomes:

  1. The sensitivity for detecting CIN2+
  2. The specificity in non-CIN2+ population
  3. The risk of developing CIN2+ in test positive cohort and test negative cohort
  4. The accuracy of detecting hrHPV

Study Type

Observational

Enrollment (Estimated)

17875

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Peking University People's Hospital
    • Henan
      • Zhengzhou, Henan, China
        • Henan Cancer Hospital
      • Zhengzhou, Henan, China
        • The Third Affiliated Hospital of Zhengzhou University
    • Hunan
      • Changsha, Hunan, China
        • Hunan Provincial Maternal and Child Health Care Hospital
    • Sichuan
      • Chengdu, Sichuan, China
        • Chengdu Women's and Children's Central Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Women's Hospital School of Medicine Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The population of clinical validity verification is all screening population, that is, women who need to undergo routine cervical cancer screening and the results of cervical cytology are unknown; Accuracy verification needs to include part of the screening population and part of the outpatient population, that is, women who intend or need to undergo colposcopy or cervical cancer screening for clinical visits.

Description

Inclusion Criteria:

  • a. Females aged 21-65; b. have a history of sexual life; c. The patients were voluntarily enrolled and signed the informed consent.

Exclusion Criteria:

  • Accuracy Verification:

Subjects meeting any of the following criteria will be excluded:

  1. Known pregnant subjects.
  2. Participants who have undergone total hysterectomy.
  3. Participants who have received cervical resection therapy or ablative therapy within 12 months, such as cryo, laser, microwave, coagulation, cryotherapy, LEEP, large loop electrosurgery (LLETZ), cold knife conization (CKC), laser conization, or ablation.

  4. Participants with poor compliance or researchers who believe that they are not suitable to participate in this study.

    • Primary screening use:

Subjects meeting any of the following criteria will be excluded:

  1. Known pregnant subjects.
  2. Participants who have undergone total hysterectomy.
  3. Participants who have received cervical resection therapy or ablative therapy within 12 months, such as cryo, laser, microwave, coagulation, cryotherapy, LEEP, large loop electrosurgery (LLETZ), cold knife conization (CKC), laser conization, or ablation.
  4. Those with known history of cervical cancer.
  5. Participants who participated in cervical cancer screening programs or underwent cervical cytology within 12 months.
  6. Participants with poor compliance or researchers who believe that they are not suitable to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Accuracy verification group
Assessment reagent urine sample HPV-PCR test result Assessment reagent vaginal secretion sample HPV-PCR test result Comparative Methods NGS Nucleic Acid Sequencing Results
Consistency verification group
Assessment reagent urine sample HPV-PCR test result Assessment reagent vaginal secretion sample HPV-PCR test result ApprovedListed Reagent Cervical Sample HPV-PCR Test Result
Efficacy and safety verification group
Thin-layer liquid-based cytology (TCT) results panel Colposcopy results Tissue biopsy pathological diagnosis result

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy verification
Time Frame: 2023/12
Calculate the positive coincidence rate, negative coincidence rate, total coincidence rate, and Kappa value of the comparison reagents and calculate the 95% confidence interval to verify the accuracy of detecting HPV infection.
2023/12
Clinical validity verification
Time Frame: 2027/06
The consistency of HPV detection of different sample types was analyzed, and the absolute risk value, relative risk value and 95% confidence interval of the development of ≥CIN2 in different primary screening types were calculated and used to verify the safety and effectiveness of the intended use of cervical cancer primary screening.
2027/06

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Collaborators

BeijingNewBiorayTechnologyCo.,Ltd.
Hangzhou Newhorizon Health Technology Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 19, 2022

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

November 4, 2022

First Submitted That Met QC Criteria

November 4, 2022

First Posted (Actual)

November 14, 2022

Study Record Updates

Last Update Posted (Estimated)

December 21, 2023

Last Update Submitted That Met QC Criteria

December 19, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NH-3004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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