Natera Ovarian Cancer Detection Assay

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03485651

Enrollment

Registered

2018-04-02

Start date

2017-12-14

Completion date

2019-12-31

Last updated

2020-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adnexal Mass

Keywords

adrexal mass, ovarian cancer, fallopian tube cancer, peritoneal cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results