NCT04461678Completed
Clinical Trial for Registration of HPV Nucleic Acid Genotyping Assay Kit
Source: ClinicalTrials.gov · Last updated 2 Jul 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 12230 (actual)
- First submitted
- 30 Jun 2020
- Start date
- 23 Aug 2020
- Primary completion date
- 26 Aug 2024
- Lead sponsor
- Becton, Dickinson and Company
- Diseases
- Cervical cancer
- NCT number
- NCT04461678
What you commit to
- Study type: Interventional
- Participants enrolled: 12230
- From 23 Aug 2020 to the primary completion date, 26 Aug 2024
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Subjects who are participating in other clinical trials of cervical disease diagnostic products
Other
- Pregnant subjects
- Subjects who have had cervical cytology samples taken in the last 12 months
Who the study is looking for
- Female subjects ≥ 21 of age and \< 65 of age
- Subjects who have signed the inform consent form
Age in the registry: 21 years to 64 years · Sex: Female · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cancer Hospital Chinese Academy of Medical Science Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
| Heping Hospital Affilated to Changzhi Medical College Coordinator of this site? Confirm its status | Changzhi | China | Unknown status |
| Women's hospital school of medicine Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Obstetrics&Gynecology Hospital of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Henan Cancer Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.