OVA1® Post Marketing Surveillance Study PS110001
Only subjects not yet referred to a gynecologic oncologist with a documented pelvic mass on physical examination and imaging, and for whom surgical intervention is planned, will be selected.
The endpoints used to assess the performance of the OVA1(TM) and its combination with the physician[Right Quote]s assessment malignancy status of a subject[Right Quote]s tumor prior to surgery is based on the comparison with a clinical reference standard, the anatomic pathology result from relevant specimens taken at surgery, and the result of OVA1(TM) from the serum sample taken when the subject was initially enrolled in the study. This assessment will be performed for the pre-menopausal and post-menopausal subjects separately.
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.
1. Identify subjects with documented adnexal tumor, obtain consent, and enroll into study
2. Draw and process preoperative whole blood, freeze serum specimens, ship to Repository (PrecisionMed)
3. Obtain source documents; complete enrollment and study CRFs
4. PrecisionMed ships frozen serum specimens to testing sites
5. Sites thaw and analyze
6. Sites send data to ACI and Vermillion
1. Subject is female and age 18 years or older.
2. Subject has a level of understanding sufficient to agree to all tests required by the protocol, must be considered reliable, and must be able to cooperate with study procedures.
3. Subject signs approved written informed consent prior to any study procedures being performed.
4. Subject must agree to venipuncture.
5. Only subjects who have not been referred to a gynecologic oncologist will be included.
6. Subject has a documented ovarian or adnexal mass with planned surgical intervention.
Note: Pregnant subjects may be study eligible.