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Clinical Trial for Registration of HPV Nucleic Acid Genotyping Assay Kit

NCT04461678 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12230

Last updated 2025-07-02

No results posted yet for this study

Summary

The objective of this study is to verify the clinical effectiveness of HPV Genotyping Nucleic Acid Assay Kit. This is a multi-center clinical study involving at least three study centers, each with screening sites. The protocol describes two study phases: Phase I is a baseline study of the screened population and ASCUS referral population (if necessary), the data of which will be submitted after the baseline study is completed; Phase II is a three-year follow-up study of the screened population, the data of which will be submitted again after the follow-up is completed.

Conditions

Interventions

DIAGNOSTIC_TEST

HPV Genotyping Nucleic Acid Assay Kit

The total sample size of screening population is approximately 12,000 cases (all females ≥ 21 years of age). Two cervical cytology samples will be collected from each subject with a tube of SurePath sample followed by a tube of PreservCyt sample. The 1st tube of SurePath liquid-based cytology sample is used for cytology test and BD Onclarity Assay HPV detection. Subjects with cytology test results ≥ ASCUS or positive HPV test results will be suggested to return for baseline colposcopy within approximately 12 weeks.

Sponsors & Collaborators

  • Becton, Dickinson and Company

    lead INDUSTRY

Principal Investigators

  • Shaokai Zhang · Henan Cancer Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
64 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-23
Primary Completion
2024-08-26
Completion
2024-08-26

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04461678 on ClinicalTrials.gov