Status:
TERMINATED
Natera Ovarian Cancer Detection Assay
Lead Sponsor:
Natera, Inc.
Conditions:
Adnexal Mass
Eligibility:
FEMALE
18+ years
Brief Summary
The purpose of this study is to enroll participants who present with an adnexal mass on imaging to develop a non-invasive ovarian cancer assay to distinguish between malignant and benign masses. The s...
Eligibility Criteria
Inclusion
- Presenting to clinic with adnexal mass suspicious of ovarian, fallopian tube, or peritoneal cancer on imaging
- Must be planning surgical resection or biopsy
- Must be treatment naïve
- Must be 18 years or older
- Able to understand and sign a written informed consent document
- Able to provide 40mL of blood (at least 20mL) for each blood draw
Exclusion
- Prior removal of either ovary for any reason
- Currently pregnant
- Blood transfusion within 3 months of study enrollment
- History of bone marrow or organ transplant
- Prior history and treatment for any malignancy, with exception of previously treated non-melanoma skin cancer.
- A medical condition that would place subject at risk as a result of the blood donation, including but not limited to bleeding disorders, chronic infectious disease, emphysema or serious anemia
Key Trial Info
Start Date :
December 14 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03485651
Start Date
December 14 2017
End Date
December 31 2019
Last Update
February 6 2020
Active Locations (1)
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1
Magee-Women's Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213