Natera Ovarian Cancer Detection Assay

Terminated

• Conditions: Adnexal Mass

• Registration Number: NCT03485651
• Lead Sponsor: Natera, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-14
• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-03-26
• Study First Posted: 2018-04-02
• Primary Completion: 2019-11-01
• Study Completion: 2019-12-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-04
• Last Update Posted: 2020-02-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 12

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Compare ctDNA from benign ovarian masses and confirmed ovarian cancers	Up to 60 months or 5 years	Examine ctDNA between benign ovarian masses and confirmed ovarian cancer cases (based on tumor pathology report). The purpose of this outcome is to determine whether cfDNA could be used to develop a non-invasive ovarian cancer assay to distinguish between malignant and benign masses.

Secondary Outcome Measures

Name	Time	Method
Determine the relationship between quantity of ctDNA and standard prognostic criteria	Up to 60 months or 5 years	Examine quantity of ctDNA and standard prognostic criteria such as tumor grade, histology and stage of cancer

Trial Locations

Locations (1)

Magee-Women's Hospital of UPMC; 🇺🇸 Pittsburgh, Pennsylvania, United States