|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P080014 / PAS001 |
| Date Original Protocol Accepted |
03/12/2009
|
| Date Current Protocol Accepted |
03/12/2009
|
| Study Name |
Cervista HPV HR Assay
|
| Device Name |
CERVISTA HPV HR AND GENFIND DNA EXTRACTION KIT
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The study is a prospective, cohort study. The study consists of women that are 30 years or older with a normal Pap test and Cervista HPV test at baseline. The enrolled subjects come back for their routine screening visits on an annual basis and have a Pap test at each follow-up visit.
|
| Study Population |
Study Population: Women 30 years or older who have a NILM cytology result at baseline. Indication: 1) To screen patients with atypical squamous cells of undetermined significance cervical cytology results to determine the need for referral to colposcopy. 2) In women 30 years and older, the Cervista HPV HR test can be used with cervical cytology to adjunctively screen to assess the presence or absence of high-risk HPV types.
|
| Sample Size |
2000 patients, 26 sites
|
| Key Study Endpoints |
There are no safety endpoints, The effectiveness endpoints include cervical cytology, colposcopy/biopsy, and high risk HPV test result.
|
| Follow-up Visits and Length of Follow-up |
The study required 3 years of follow-up. Follow-up inculdes annual visits.
|
| Interim or Final Data Summary |
| Interim Results |
Saftey information not applicable
|
| Actual Number of Patients Enrolled |
2026
|
| Actual Number of Sites Enrolled |
26
|
| Patient Follow-up Rate |
3 years
|
| Final Safety Findings |
The cumulative risk of ¡ÝCIN2 after 3 years among subjects who had a positive Cervista HPV HR result was 0.013 compared to 0.001 among subjects with HPV negative results when followed for 3 years (p=0.002).The clinical sensitivity, specificity, NPV and PPV of the test For detection of >= CIN2, based on 6diseased subjects.
Sensitivity = 66.7% (95% CI: 30.0-90.3) Specificity = 81.6% (95% CI: 79.4 ¨C 83.5)
Positive predictive value = 1.6% (95% CI: 0.6 ¨C 2.2) Negative predictive value = 99.8% (95% CI: 99.6-100.0)
|
| Final Effect Findings |
Please see safety findings.
|
| Study Strengths & Weaknesses |
Of the 2026 women enrolled in the PAS, only 6 had the study outcomes/CIN2+, namely 4 HPV positive and 2 HPV negative after 3 years. 36 subjects had missing data for CIN2+ determination in the PAS as compared to the 6 CIN2+ evaluated in the PAS. However, missing data analyses evaluated the study results as robust. Another weakness is the generalizability of the study as the absolute 3 year cumulative risk of developing ¡ÝCIN2 in Cervista HPV HR [1.1% (4/362)] positive women is lower in the Cervista NILM ¡Ý30 population in comparison to cross-sectional and longitudinal data using other approved assays.
|
| Recommendations for Labeling Changes |
It is recommended that the label be updated to reflect the study results for the three year follow-up of women with NILM ¡Ý30 with normal cytology.
|
