Clinical Trial for Registration of HPV Nucleic Acid Genotyping Assay Kit
Study Details
Study Description
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 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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: screening population
|
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.
|
Outcome Measures
Primary Outcome Measures
- Verification of the accuracy of nucleic acid assay [12 weeks]
The results of HPV Assay of test product and reference product
- PLR and NLR in ASCUS population [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 [3 years]
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
- HPV risk of ≥ CIN2 in Primary screening [3 years]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Female subjects ≥ 21 of age and < 65 of age
-
Subjects who have signed the inform consent form
Exclusion Criteria:
-
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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Cancer Hospital Chinese Academy of Medical Science | Beijing | Beijing | China | |
2 | Henan Cancer Hospital | Zhengzhou | Henan | China | |
3 | Heping Hospital Affilated to Changzhi Medical College | Changzhi | Shanxi | China |
Sponsors and Collaborators
- Becton, Dickinson and Company
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BDS-19CNHPV