Natera Ovarian Cancer Detection Assay

Stopped early

Conditions studied: Adnexal Mass

In brief

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 study will collect blood, tissue, and health information from these individuals.

Key facts

Study ID

NCT03485651

Run by

Natera, Inc.

People needed

12

Starts

2017-12-14

Expected to finish

2019-12-31

Last updated by the study team

2020-02-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Magee-Women's Hospital of UPMC — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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