- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03485651
Natera Ovarian Cancer Detection Assay
February 4, 2020 updated by: Natera, Inc.
Prospective Collection of Samples for Development of the Natera Ovarian Cancer Detection Assay
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.
Study Overview
Status
Terminated
Conditions
Study Type
Observational
Enrollment (Actual)
12
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Magee-Women's Hospital of UPMC
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Compare ctDNA from benign ovarian masses and confirmed ovarian cancers
Time Frame: Up to 60 months or 5 years
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Up to 60 months or 5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 14, 2017
Primary Completion (Actual)
November 1, 2019
Study Completion (Actual)
December 31, 2019
Study Registration Dates
First Submitted
March 9, 2018
First Submitted That Met QC Criteria
March 26, 2018
First Posted (Actual)
April 2, 2018
Study Record Updates
Last Update Posted (Actual)
February 6, 2020
Last Update Submitted That Met QC Criteria
February 4, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Ovarian Neoplasms
- Carcinoma, Ovarian Epithelial
Other Study ID Numbers
- 15-025-NCT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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