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| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS110001 / PSS001 |
| Date Original Plan Accepted |
03/15/2012
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| Date Current Plan Accepted |
03/15/2012
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| Study Name |
OVA1 Performance in Pre and Post Menopausal Women
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| Device Name |
Ova1
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| Root Document Number |
K081754
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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 |
Concurrent Control
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| Analysis Type |
Analytical
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This is a cross-sectional study to determine: (1) the effect of menopausal status on OVA1TM performance when the test is used as labeled.(2). To determine if the increase in negative predictive value (with the addition of OVA1TM result to pre-surgical assessment alone) is statistically greater than the negative predictive value of the pre-surgical assessment for each of the subpopulations from surveillance of OVA1TM performance separately for pre-menopausal women and for post-menopausal women. (3) To determine if the positive predictive value (with the addition of the OVA1TM result to pre-surgical assessment alone) is clinically acceptable for each of the subpopulations from surveillance of OVA1TM performance separately for premenopausal women and for post-menopausal women.
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| Study Population |
Only women not yet referred to a gynecologic oncologist with a documented pelvic mass on physical examination and imaging, and for whom surgical intervention is planned.
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| Sample Size |
"Up to 35 patient recruitment sites (a minimum of 28 Primary Care/ObGyn and 7 ObGyn/GYN/ONC practices/clinics). Enrolment will continue until at least 1500 pre-menopausal and 400 post-menopausal subjects who meet the Inclusion/Exclusion criteria and who are evaluable with both a pathology assessment and OVA1 test result are recruited."
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| Key Study Endpoints |
"The endpoints used to assess the performance of the OVA1 in combination with the physician assessment are the non-gynecologic oncologist assessment of malignancy status of a subject's tumor prior to surgery. The anatomic pathology result from relevant specimens taken at surgery, and the result of the OVA1 test from the serum sample taken when the subject was initially enrolled in the study.
The safety of the study procedures will be monitored and adverse events occurring within 24 hours of the blood draw and before surgery will be recorded. Sites are asked to report and handle an adverse event in the manner that is usual and customary for the site. Adverse events will be followed until the subject has completed the study protocol. Malignancies will be determined from the surgical and pathology reports. These will be compared to the pre-surgical assessment and the combination of the pre-surgical assessment of malignancy with the result of the OVA1 test. Menopausal status will be obtained from the assessment of the physician as recorded on the CRF and with at least 6 months since their last menstruation to confirm postmenopausal status."
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| Follow-up Visits and Length of Follow-up |
"After enrollment the subject has a preoperative blood draw (up to 80 mL) for biomarker studies. The blood is processed and serum is frozen at the collection site. The serum specimens are shipped to a central biorepository, and stored at -65°C to -85°C until shipment to testing sites. Subject demographic and clinicopathological information is collected on eCRFs.After enrollment, subjects must undergo surgery within 12 weeks for their ovarian or adnexal mass. Surgical outcome data is collected in the eCRF and comprises the pathology report as well as the surgical report."
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| Interim or Final Data Summary |
| Interim Results |
As of March 9, 2015., there are 42 sites received IRB approvals and initiated the study, of which 11 active sites (i.e. sites enrolled any subjects each month) and 26 open sites (sites open and continuing participation in the study during each month), and a total of 7 sites were closed due to prolonged inadequate enrollment activity between March 2014 and March 9, 2015.
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