Cervical CancerNCT04461678
Clinical Trial for Registration of HPV Nucleic Acid Genotyping Assay Kit
A study testing HPV Genotyping Nucleic Acid Assay Kit in people with Cervical Cancer, run by Becton, Dickinson and Company at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 64 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- HPV Genotyping Nucleic Acid Assay Kit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,230 participants
- Where
- 5 sitesChina
- Study dates
- 23 Aug 2020to 26 Aug 2024
- Phase
- Interventional
- 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 21 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female subjects ≥ 21 of age and < 65 of age
- Subjects who have signed the inform consent form
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality
Heping Hospital Affilated to Changzhi Medical College
Changzhi, Shanxi
Women's Hospital School of Medicine Zhejiang University
Hangzhou, Zhejiang
Obstetrics&Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality
Henan Cancer Hospital
Zhengzhou, Henan
About this study
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.
Read the 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 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. Subjects with unsatisfactory cytology results may be recalled for a second sampling 2 months after the first collection of the cervical sample. In case of visible lesions under colposcopy, a biopsy of tissues at the site of the lesion will be performed (an ECC will be performed if necessary); in case of no visible lesions, randomly biopsy and/or ECC will be performed if necessary. Patients with histopathological findings ≥ CIN2 will complete the study (see Figure 1). In the baseline colposcopy phase, if the subject is pregnant, the subject will be withdrawn from the study without colposcopy performed.
Based on the age of the subjects, different cytology results, and Surepath BD Onclarity Assay HPV results, a total of more than 500 PreservCyt samples will be selected for BD Onclarity Assay test and the HPV test for control product. For inconsistent results, a third-party sequencing method will be used to determine the final result.
SurePath sample and PreserveCyt sample collected from the same subject will be used for BD OnclarityTM Assay test to compare the consistency of test results, at least 200 samples will be enrolled only for this test. Subjects will exit the study after those HPV test without any other test.
ASCUS referral population study Female subjects with known ASCUS cytology results will be enrolled in the referral population (21-65 years old) if necessary. Female subjects with an ASCUS cytology result will be recalled to sign the informed consent to participate in the study and undergo colposcopy (within 12 weeks from the cytology sampling). For referral population, the remaining cervical samples collected prior to enrollment for cytology test will be tested with the BD Onclarity Assay HPV (see Figure 2). Such population is only used for the assessment of ASCUS triage indications and does not enter the follow-up longitudinal follow-up study.
- Conditions
- Cervical Cancer
- Being tested
- HPV Genotyping Nucleic Acid Assay Kit
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV Genotyping Nucleic Acid Assay KitDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Screening population and ASCUS referral population | Experimental | The screening population: Two cervical cytology samples will be collected from each subject. 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. In case of visible lesions under colposcopy, a biopsy of tissues at the site of the lesion will be performed; in case of no visible lesions, randombiopsy and/or ECC will be performed. Patients with histopathological results ≥ CIN2 will completed the study.
ASCUS referral population: Female subjects with an ASCUS cytology result will be recalled undergo colposcopy, the remaining samples for cytology test collected prior to enrollment will be used for BD Onclarity Assay HPV test. Receives: Diagnostic Test: HPV Genotyping Nucleic Acid Assay Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verification of the accuracy of nucleic acid assay
The results of HPV Assay of test product and reference product
Measured: 12 weeks
PLR and NLR in ASCUS population
Clinical sensitivity (Sn), clinical specificity (Sp), positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR) and negative likelihood ratio (NLR) of carcinogenic HPV+ in case of ≥CIN2.
Measured: 12 weeks
HPV risk of ≥ CIN2 in NILM 30+ population
- absolute risk and 95%CI of HPV+, HPV 16 / 18/45 +, HPV31 / 33_58 / 52; HPV51 / 35_39_68 / 56_59_66 + and HPV- in case of ≥ CIN2
- Relative risk and 95%CI of HPV+ and HPV- in case of ≥ CIN2
- Relative risk and 95%CI of HPV 16 / 18/45 and HPV- in case of ≥ CIN2
- Relative risk and 95%CI of HPV 31 / 33_58 / 52 and HPV- in case of ≥ CIN2
- Relative risk and 95%CI of HPV 51, 35 / 39 / 68, 56 / 59/66 and HPV- in case of ≥ CIN2
- Relative risk and 95%CI of HPV 16 / 18/45 + and HPV 31 / 33_58 / 52 + in case of ≥ CIN2
- Relative risk and 95%CI of HPV 16 / 18/45 + and HPV 51, 35 / 39 / 68, 56 / 59/66 + in case of ≥ CIN2
- Relative risk and 95%CI of HPV 31 / 33_58 / 52 + and HPV 51, 35 / 39 / 68, 56 / 59/66 + in case of ≥ CIN2
Measured: 3 years
HPV risk of ≥ CIN2 in Primary screening
- Absolute risk and 95%CI of NILM, HPV-, HPV +, HPV16 / 18/45 +, HPV 31 / 33_58 / 52 +, HPV 51, 35 / 39 / 68, 56 / 59/66 + and HPV in case of ≥ CIN2
- Relative risk and 95%CI of NILM and HPV- in case of ≥ CIN2
- Relative risk and 95%CI of HPV+ and HPV- in case of ≥ CIN2
- Relative risk and 95%CI of HPV 16 / 18/45+ and HPV- in case of ≥ CIN2
- Relative risk and 95%CI of HPV 31 / 33_58 / 52 and HPV- in case of ≥ CIN2
- Relative risk and 95%CI of HPV 51, 35 / 39 / 68, 56 / 59/66 and HPV- in case of ≥ CIN2
- Relative risk and 95%CI of HPV 16 / 18/45 + and HPV 31 / 33_58 / 52 + in case of ≥ CIN2
- Relative risk and 95%CI of HPV 16 / 18/45 + and HPV 51, 35 / 39 / 68, 56 / 59/66 + in case of ≥ CIN2
- Relative risk and 95%CI of HPV 31 / 33_58 / 52 + and HPV 51, 35 / 39 / 68, 56 / 59/66 + in case of ≥ CIN2
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 posted8 Jul 2020
- Study start23 Aug 2020
- Primary completion26 Aug 2024
- Study completion26 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12,230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shaokai Zhang, Principal investigator, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04461678
- Sponsor's protocol ID
- BDS-19CNHPV
- Status last verified
- Jun 2025
- First submitted
- 30 Jun 2020
- Last updated
- 2 Jul 2025
- 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 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial for Registration of HPV Nucleic Acid Genotyping Assay Kit
- ClinicalTrials.gov ID
- NCT04461678
- Acronym / sponsor ID
- BDS-19CNHPV
- Conditions
- Cervical Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12,230 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- 23 Aug 2020 (actual)
- Primary completion
- 26 Aug 2024 (actual)
- Study completion
- 26 Aug 2024 (actual)
- First posted
- 8 Jul 2020 (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 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.
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 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. Subjects with unsatisfactory cytology results may be recalled for a second sampling 2 months after the first collection of the cervical sample. In case of visible lesions under colposcopy, a biopsy of tissues at the site of the lesion will be performed (an ECC will be performed if necessary); in case of no visible lesions, randomly biopsy and/or ECC will be performed if necessary. Patients with histopathological findings ≥ CIN2 will complete the study (see Figure 1). In the baseline colposcopy phase, if the subject is pregnant, the subject will be withdrawn from the study without colposcopy performed.
Based on the age of the subjects, different cytology results, and Surepath BD Onclarity Assay HPV results, a total of more than 500 PreservCyt samples will be selected for BD Onclarity Assay test and the HPV test for control product. For inconsistent results, a third-party sequencing method will be used to determine the final result.
SurePath sample and PreserveCyt sample collected from the same subject will be used for BD OnclarityTM Assay test to compare the consistency of test results, at least 200 samples will be enrolled only for this test. Subjects will exit the study after those HPV test without any other test.
ASCUS referral population study Female subjects with known ASCUS cytology results will be enrolled in the referral population (21-65 years old) if necessary. Female subjects with an ASCUS cytology result will be recalled to sign the informed consent to participate in the study and undergo colposcopy (within 12 weeks from the cytology sampling). For referral population, the remaining cervical samples collected prior to enrollment for cytology test will be tested with the BD Onclarity Assay HPV (see Figure 2). Such population is only used for the assessment of ASCUS triage indications and does not enter the follow-up longitudinal follow-up study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening population and ASCUS referral population | Experimental | Diagnostic Test: HPV Genotyping Nucleic Acid Assay KitThe screening population: Two cervical cytology samples will be collected from each subject. 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. In case of visible lesions under colposcopy, a biopsy of tissues at the site of the lesion will be performed; in case of no visible lesions, randombiopsy and/or ECC will be performed. Patients with histopathological results ≥ CIN2 will completed the study. ASCUS referral population: Female subjects with an ASCUS cytology result will be recalled undergo colposcopy, the remaining samples for cytology test collected prior to enrollment will be used for BD Onclarity Assay HPV test. |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female subjects ≥ 21 of age and < 65 of age
- Subjects who have signed the inform consent form
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| HPV Genotyping Nucleic Acid Assay KitThe 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. | Diagnostic test | Screening population and ASCUS referral population |
Primary outcome
Verification of the accuracy of nucleic acid assay
Time frame: 12 weeks
The results of HPV Assay of test product and reference product
PLR and NLR in ASCUS population
Time frame: 12 weeks
Clinical sensitivity (Sn), clinical specificity (Sp), positive predictive value (PPV), negative predictive value (NPV), positive likelihood ratio (PLR) and negative likelihood ratio (NLR) of carcinogenic HPV+ in case of ≥CIN2.
HPV risk of ≥ CIN2 in NILM 30+ population
Time frame: 3 years
1. absolute risk and 95%CI of HPV+, HPV 16 / 18/45 +, HPV31 / 33_58 / 52; HPV51 / 35_39_68 / 56_59_66 + and HPV- in case of ≥ CIN2 2. Relative risk and 95%CI of HPV+ and HPV- in case of ≥ CIN2 3. Relative risk and 95%CI of HPV 16 / 18/45 and HPV- in case of ≥ CIN2 4. Relative risk and 95%CI of HPV 31 / 33_58 / 52 and HPV- in case of ≥ CIN2 5. Relative risk and 95%CI of HPV 51, 35 / 39 / 68, 56 / 59/66 and HPV- in case of ≥ CIN2 6. Relative risk and 95%CI of HPV 16 / 18/45 + and HPV 31 / 33_58 / 52 + in case of ≥ CIN2 7. Relative risk and 95%CI of HPV 16 / 18/45 + and HPV 51, 35 / 39 / 68, 56 / 59/66 + in case of ≥ CIN2 8. Relative risk and 95%CI of HPV 31 / 33_58 / 52 + and HPV 51, 35 / 39 / 68, 56 / 59/66 + in case of ≥ CIN2
HPV risk of ≥ CIN2 in Primary screening
Time frame: 3 years
1. Absolute risk and 95%CI of NILM, HPV-, HPV +, HPV16 / 18/45 +, HPV 31 / 33_58 / 52 +, HPV 51, 35 / 39 / 68, 56 / 59/66 + and HPV in case of ≥ CIN2 2. Relative risk and 95%CI of NILM and HPV- in case of ≥ CIN2 3. Relative risk and 95%CI of HPV+ and HPV- in case of ≥ CIN2 4. Relative risk and 95%CI of HPV 16 / 18/45+ and HPV- in case of ≥ CIN2 5. Relative risk and 95%CI of HPV 31 / 33_58 / 52 and HPV- in case of ≥ CIN2 6. Relative risk and 95%CI of HPV 51, 35 / 39 / 68, 56 / 59/66 and HPV- in case of ≥ CIN2 7. Relative risk and 95%CI of HPV 16 / 18/45 + and HPV 31 / 33_58 / 52 + in case of ≥ CIN2 8. Relative risk and 95%CI of HPV 16 / 18/45 + and HPV 51, 35 / 39 / 68, 56 / 59/66 + in case of ≥ CIN2 9. Relative risk and 95%CI of HPV 31 / 33_58 / 52 + and HPV 51, 35 / 39 / 68, 56 / 59/66 + in case of ≥ CIN2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2025.
- 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.
Shaokai Zhang principal investigator
Henan Cancer Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HPV Genotyping Nucleic Acid Assay Kit in people with Cervical Cancer, run by Becton, Dickinson and Company at 5 sites 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 5 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: finished, as of the sponsor's last update on 2 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verification of the accuracy of nucleic acid assay (time frame: 12 weeks). The study lists 4 primary outcomes in all. 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 2 Jul 2025.