Status:
COMPLETED
Clinical Trial for Registration of HPV Nucleic Acid Genotyping Assay Kit
Lead Sponsor:
Becton, Dickinson and Company
Conditions:
Cervical Cancer
Eligibility:
FEMALE
21-64 years
Phase:
NA
Brief 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 sc...
Detailed Description
Baseline study of the screened population: The total sample size of screened population is approximately 12,000 cases (all females ≥ 21 years of age). Two cervical cytology samples will be collected ...
Eligibility Criteria
Inclusion
- Female subjects ≥ 21 of age and \< 65 of age
- Subjects who have signed the inform consent form
Exclusion
- Pregnant subjects
- Subjects who have had cervical cytology samples taken in the last 12 months
- Subjects who have previously undergone a total hysterectomy
- Subjects who have previously undergone cone resection, LEEP, cervical laser surgery, cervical cryosurgery or uterine ablation within 3 years
- Subjects who are participating in other clinical trials of cervical disease diagnostic products
Key Trial Info
Start Date :
August 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2024
Estimated Enrollment :
12230 Patients enrolled
Trial Details
Trial ID
NCT04461678
Start Date
August 23 2020
End Date
August 26 2024
Last Update
July 2 2025
Active Locations (5)
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1
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
2
Henan Cancer Hospital
Zhengzhou, Henan, China
3
Obstetrics&Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, China
4
Heping Hospital Affilated to Changzhi Medical College
Changzhi, Shanxi, China