|
|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P100020 S017/ PAS001 |
| Date Original Protocol Accepted |
07/03/2018
|
| Date Current Protocol Accepted |
|
| Study Name |
COB-HPV-301 Post Approval Study
|
| Device Name |
COBAS HPV TEST, 240 TESTS; COBAS HPV TEST, 960 TESTS
|
| General Study Protocol Parameters |
| Study Design |
Cross-Sectional Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This study includes 10,000 women, 25 years or older from a general screening population for cervical disease. All subjects have results of the cytology test from specimens collected in Sure PathPreservative Fluid and cobas HPV Test results with SurePath specimens. Subjects with either abnormal or UNSAT Pap or positive cobas HPV Test results are referred to colposcopy/biopsy procedures. In addition, 250 subjects with NILM cytology and negative HPV results will be referred to colposcopy/biopsy. The study provides additional data regarding the clinical performance of the cobas HPV Test with SurePath samples as sensitivity, specificity, likelihood ratios, and predictive values for women 30 years or older and for women 25 years or older with ASC-US (atypical squamous cells of undetermined significance) cervical cytology test results.
|
| Study Population |
Women 25 years of age or older from a general screening population for cervical disease
|
| Sample Size |
10,000 or more
|
| Key Study Endpoints |
greater than or equal to CIN2 (Cervical Intraepithelial Neoplasia) and greater than or equal to CIN3 by colposcopic examination
|
| Follow-up Visits and Length of Follow-up |
A need for the follow-up study and the length of the follow-up depends on the estimates of clinical performance of the cobas HPV Test with SurePath specimens. Decision about the need of a follow-up study will be made based on the difference in risks of cervical disease for women with negative cobas HPV Test results and/or with positive Other 12 HR HPV cobas HPV Test and NILM cytology results estimated in the study in comparison with the risks for similar groups of women in the ATHENA study.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
8095 women aged 30 years and older with NILM cytology were enrolled in the clinical study. Of those enrolled, 8088 women were evaluable.
|
| Actual Number of Sites Enrolled |
Subjects were enrolled at 11 U.S. sites.
|
| Patient Follow-up Rate |
Not applicable.
|
| Final Safety Findings |
No severe adverse events were reported.
|
| Final Effect Findings |
In the current study, it was demonstrated that the risks of cervical disease (greater than or equal to CIN2 and greater than or equal to CIN3 determined by colposcopy/biopsy) for women with HPV 16/18 positive results or with 12 Other HR HPV positive results obtained by cobas HPV Test in SurePath Preservative Fluid were higher than the risk of the cervical disease for women with cobas HPV Test negative results. In addition, these risks were compared to the corresponding risks when using an FDA-approved HPV test and the study demonstrated that these risks were similar.
|
| Study Strengths & Weaknesses |
Study strength: Women who were HPV negative and had NILM cytology were sent to colposcopy in the clinical study. The colposcopy results allowed estimation of the sensitivity and specificity of the device.
Study weakness:
Biopsy results of greater than or equal to CIN2 in NILM HPV negative women may not be definitive of cervical disease without follow-up information.
|
| Recommendations for Labeling Changes |
Labeling incorporating the data from post approval study was submitted and approved.
|
