Natera Ovarian Cancer Detection Assay

Natera

Status: Terminated

Conditions: Adnexal Mass

Study type: Observational

Funder types: Industry

Identifiers

NCT03485651

15-025-NCT

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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