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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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OVA1 Performance in Pre and Post Menopausal Women

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Study Status Completed
522 Number / Requirement Number PS110001 / PSS001
Date Current Plan Accepted 03/15/2012
Study Name OVA1 Performance in Pre and Post Menopausal Women
Root Document Number K081754 
General Study Protocol Parameters
Study Design Cross-Sectional 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 Design Description 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.

Study Population Description 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.

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.


Data Collection "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."

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."

Interim or Final Data Summary
Interim Safety Information 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.

OVA1 Performance in Pre and Post Menopausal Women Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
6 month report 09/13/2012 09/13/2012 On Time
1 yr report 03/14/2013 03/14/2013 On Time
18 month report 09/12/2013 09/13/2013 Overdue/Received
2 yr report 03/15/2014 03/18/2014 Overdue/Received
3 yr report 03/15/2015 03/16/2015 Overdue/Received
4 yr report 03/15/2016 03/15/2016 On Time

  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • In May 2008, the oversight responsibility of the 522 Postmarket Surveillance Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH). DEPI continues to build the 522 program.
  • CDRH has established an automated internal tracking system that efficiently identifies the reporting status of active 522 PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 PS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.


Contact Information

Cheryl Reynolds
Project Manager, 522 Postmarket Surveillance (PS) Studies Program
Food and Drug Administration
10903 New Hampshire Ave
Silver Spring, MD 20993-0002

Phone: (301) 796-6068
Fax: (301) 847-8140