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Natera Ovarian Cancer Detection Assay

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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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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