Natera Ovarian Cancer Detection Assay

NCT03485651 | Terminated

• 1 other identifier: 15-025-NCT
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Adnexal Mass

Keywords

adrexal mass; ovarian cancer; fallopian tube cancer; peritoneal cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Determine the relationship between quantity of ctDNA and standard prognostic criteria

  Up to 60 months or 5 years

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals who present with an adnexal mass on imaging and meet the eligibility criteria. Up to 300 total participants may be enrolled in the study, or until samples from at least 100 malignant cases have been collected.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Natera, Inc.: lead

Study Sites (1)

Magee-Women's Hospital of UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples will be retained for research

MeSH Terms

Conditions

Ovarian Neoplasms; Fallopian Tube Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Fallopian Tube Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: April 2, 2018
• Study Start: December 14, 2017
• Primary Completion: November 1, 2019
• Study Completion: December 31, 2019
• Last Updated: February 6, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)