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TerminatedNCT03485651Updated Feb 6, 2020

Natera Ovarian Cancer Detection Assay

An observational study in Adnexal Mass, sponsored by Natera, Inc.. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-06.

Sponsored by Natera, Inc. · Observational

Why this study was terminated
Poor accrual
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Adnexal Mass

Keywords

  • adrexal mass
  • ovarian cancer
  • fallopian tube cancer
  • peritoneal cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

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

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
05

What researchers measure

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.

    Time frame: Up to 60 months or 5 years

Secondary outcomes

  1. 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

    Time frame: Up to 60 months or 5 years

06

Study locations

1 site
  • Magee-Women's Hospital of UPMC
    Pittsburgh, Pennsylvania 15213, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03485651
Lead sponsor
Natera, Inc.
Responsible party
Sponsor
First posted
Apr 2, 2018
Start date
Dec 14, 2017
Primary completion
Nov 1, 2019
Completion
Dec 31, 2019
Last update
Feb 6, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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