Natera Ovarian Cancer Detection Assay

Adnexal Mass Clinical Trial

Official title:

Prospective Collection of Samples for Development of the Natera Ovarian Cancer Detection Assay

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03485651
• Other study ID #: 15-025-NCT
• Status: Terminated
• Start date: December 14, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2020
• Source: Natera, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: December 31, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adnexal Mass
• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms

Locations

Country	Name	City	State
United States	Magee-Women's Hospital of UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Natera, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare ctDNA from benign ovarian masses and confirmed ovarian cancers	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.	Up to 60 months or 5 years
Secondary	Determine the relationship between quantity of ctDNA and standard prognostic criteria	Examine quantity of ctDNA and standard prognostic criteria such as tumor grade, histology and stage of cancer	Up to 60 months or 5 years