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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P160037 S017/ PAS001 |
| Date Original Protocol Accepted |
05/14/2024
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| Date Current Protocol Accepted |
03/12/2025
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| Study Name |
SHIP-Sub-Protocol LMI-001-A-S01
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| Device Name |
BD Onclarity HPV Assay
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| General Study Protocol Parameters |
| Study Design |
Cross-Sectional Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: At least 22 yrs
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| Detailed Study Protocol Parameters |
| Study Objectives |
The study will include 500 or more individuals with a cervix, 25 years or older, with referrals to colposcopy based on previous positive HPV test or abnormal cytology results and/or referrals to cervical excisional procedure. The study will provide additional data regarding clinical performance of the BD Onclarity HPV Assay with vaginal specimens in a U.S. population. The clinical sensitivity, clinical specificity and false positive rate and false negative rate in detecting precancer/cancer as well as the corresponding ratio between vaginal and cervical specimens will be evaluated. Additionally, the concordance of the BD Onclarity HPV Assay results between the two specimen types will be evaluated.
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| Study Population |
Individuals with a cervix, 25 years or older, who come to colposcopy with a referral based on previous positive HPV test or abnormal cytology results and who come to cervical excisional procedure with a referral. There is no comparison group.
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| Sample Size |
500 or more
Study sites will be 10 or more
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| Key Study Endpoints |
The clinical sensitivity, clinical specificity and false positive rate and false negative rate in detecting precancer/cancer as well as the corresponding ratio between vaginal and cervical specimens.
The concordance of the BD Onclarity HPV Assay results between the two specimen types.
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| Follow-up Visits and Length of Follow-up |
No follow-up, unless required for SOC clinical care purposes
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
554
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| Actual Number of Sites Enrolled |
13
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| Patient Follow-up Rate |
N/A
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| Final Safety Findings |
No severe adverse events were reported.
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| Final Effect Findings |
- The sensitivities of the assay for detecting greater than or equal to CIN2 with self-collected vaginal (SV) and clinician-collected cervical (CC) specimens are 83.7% and 90.7%, respectively, with a ratio of sensitivity (SV:CC) of 0.923.
- The sensitivities of the assay for detecting greater than or equal to CIN3 with SV and CC are 89.2% and 96.9%, respectively, with a ratio of sensitivity (SV:CC) of 0.921.
- The false positive rates of the assay with SV and CC are 68.1% and 59.9%, respectively, with a ratio of false positive rate (SV:CC) of 1.138.
- The specificities of the assay with SV and CC are 31.9% and 40.1%, respectively, with a ratio of specificity (SV:CC) of 0.795.
- For detection of HR HPV, the positive percent agreement and negative percent agreement of SV specimen as compared to CC specimen are 92.4% and 67.9%, respectively.
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| Study Strengths & Weaknesses |
Study strength: The study provided additional data regarding clinical performance of the BD Onclarity HPV Assay with vaginal specimens in a U.S. population.
Study weakness: The study subject enrollment was based on cervical sample test result.
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| Recommendations for Labeling Changes |
Recommended labeling changes: addition of PAS results as well as appropriate labeling mitigations for the observed performance for self-collected vaginal specimens.
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