ClinicalTrials.gg
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

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12
Ages
18 Years and older
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 1,778 studies in Ovarian Neoplasms with a site in United States — 280 open to participants now, 455 under way, 46 of them phase 3. Ovarian Neoplasms · United States.

Enrollment
175th of 195
12 · median 176
Started
2017
with 76 others
Observational
196 of 1,778
39 open now
Registered
1,107th of 1,778
by date

Among the 1,778 studies in Ovarian Neoplasms with a site in United States, this one is the 175th largest by enrollment of the 195 observational ones that give a count, is one of 77 that started in 2017, is one of 196 observational ones, and was the 1,107th registered.

Ovarian Neoplasms

3,385 studies on the registry are indexed under Ovarian Neoplasms; 792 are open to participants now.

Browse Ovarian Neoplasms studies →

Open to participants now

280 of the 1,778 studies in Ovarian Neoplasms with a site in United States are open now. Recruiting first, the newest first:

275 more — sign in →

All 280 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 604 Ovarian Neoplasms studies recruiting now, 441 (73%) set no upper age limit and 107 (18%) stop at 75 or younger; 39 take children under 18; 45 take healthy volunteers.

This study: 18 Years and older · female · no healthy volunteers.

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02

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.

03

Conditions studied

  • Adnexal Mass

Keywords

  • adrexal mass
  • ovarian cancer
  • fallopian tube cancer
  • peritoneal cancer
04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Presenting to clinic with adnexal mass suspicious of ovarian, fallopian tube, or peritoneal cancer on imaging
  • Must be planning surgical resection or
  • Must be treatment naïve
  • Must be 18 years or older
  • Able to understand and sign a written 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 , 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
06

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

07

Study locations

1 site
  • Magee-Women's Hospital of UPMC
    Pittsburgh, Pennsylvania 15213, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2017 to primary completion in Nov 2019, 22 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 9, 2018
First posted
Apr 2, 2018
StartActual
Dec 14, 2017
Primary completionActual
Nov 1, 2019
CompletionActual
Dec 31, 2019
Last update
Feb 6, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 6, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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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Discussion

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