Adnexal MassNCT03485651
Natera Ovarian Cancer Detection Assay
An observational study of Adnexal Mass, run by Natera, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adnexal Mass
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2017to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee-Women's Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: 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.
- Conditions
- Adnexal Mass
- Keywords
- adrexal mass, ovarian cancer, fallopian tube cancer, peritoneal cancer
- Medical subject headings
- Ovarian Neoplasms, Fallopian Tube Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Up to 60 months or 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2018
- Study start14 Dec 2017
- Primary completion1 Nov 2019
- Study completion31 Dec 2019
Why it stopped: Poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adnexal MassStudies of the same condition, open and under way.
- More trials run by Natera, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Natera, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03485651
- Sponsor's protocol ID
- 15-025-NCT
- Status last verified
- Feb 2020
- First submitted
- 9 Mar 2018
- Last updated
- 6 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Collection of Samples for Development of the Natera Ovarian Cancer Detection Assay
- ClinicalTrials.gov ID
- NCT03485651
- Acronym / sponsor ID
- 15-025-NCT
- Conditions
- Adnexal Mass
- Keywords
- adrexal mass, ovarian cancer, fallopian tube cancer, peritoneal cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Natera, Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 1 Nov 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 2 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Determine the relationship between quantity of ctDNA and standard prognostic criteria
Time frame: Up to 60 months or 5 years
Results and safety
The study was stopped early (reason given: Poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Individual participant dataSharing planned: No
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MIRRORS-FROZEN - Comparing Open Vs Robotic Surgery in the Management of Women With Complex Pelvic Adnexal Masses ≤ 8cm.
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A Diagnostic Test to Evaluate Cancer Risk Before Surgery in Women With an Ovarian Mass
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adnexal Mass, run by Natera, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor accrual). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare ctDNA from benign ovarian masses and confirmed ovarian cancers (time frame: Up to 60 months or 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.