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Natera Ovarian Cancer Detection Assay

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03485651
Recruitment Status : Terminated (Poor accrual)
First Posted : April 2, 2018
Last Update Posted : February 6, 2020
Sponsor:
Information provided by (Responsible Party):
Natera, Inc.

Study Description
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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.

Condition or disease
Adnexal Mass

Study Design
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Study Type : Observational
Actual Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Collection of Samples for Development of the Natera Ovarian Cancer Detection Assay
Actual Study Start Date : December 14, 2017
Actual Primary Completion Date : November 1, 2019
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Compare ctDNA from benign ovarian masses and confirmed ovarian cancers [ Time Frame: 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 :
  1. Determine the relationship between quantity of ctDNA and standard prognostic criteria [ Time Frame: Up to 60 months or 5 years ]
    Examine quantity of ctDNA and standard prognostic criteria such as tumor grade, histology and stage of cancer


Biospecimen Retention:   Samples With DNA
Samples will be retained for research

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03485651


Locations
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United States, Pennsylvania
Magee-Women's Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Natera, Inc.
More Information
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Responsible Party: Natera, Inc.
ClinicalTrials.gov Identifier: NCT03485651    
Other Study ID Numbers: 15-025-NCT
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: February 6, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Natera, Inc.:
adrexal mass
ovarian cancer
fallopian tube cancer
peritoneal cancer
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
 Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type