Adnexal MassOVAnexNCT04487405
A Multivariate Index Assay for Ovarian Cancer Risk Assessment in Women With Adnexal Mass and High-Risk Germline Variants
An observational study of Adnexal Mass, run by Aspira Women's Health at 9 sites in United States.
Trial summary
The objective of this project is to validate the sensitivity, specificity, positive predictive value and negative predictive values of the AMRA blood test for assessing risk of cancer in women at high risk for ovarian cancer, due to the presence of a symptomatic adnexal mass. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Adnexal Mass
- What is being tested?
- OVAnex
- Type of treatment
- Medical device
- How many people
- 721 participants
- Where
- 9 sitesUnited States
- Study dates
- 25 Jun 2020to 15 Dec 2023
- 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: Adult women with an ovarian adnexal mass, or in follow up due to the presence of BRCA1/2 and other germline DNA variants.
Who may be able to join
- Female patient, 18 years of age or older diagnosed with an ovarian adnexal mass, or in follow-up due to the presence of BRCA1/2 and other germline DNA variants.
- Patient reviewed, understood, and provided the PI with written informed consent to allow blood specimen to be used for research and release of medical information.
Who cannot join
- Patient is less than 18 years of age
- Patient is not being treated in the U.S.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Hill Country OBGYN Associates
Austin, Texas, 78748
Women's Health Arizona
Chandler, Arizona, 85224
Seven Hills Clinical Research Group
Cincinnati, Ohio, 45211
MidTown OBGYN
Columbus, Georgia, 31901
Premier OBGYN of Minnesota
Eden Prairie, Minnesota, 55344
Altus Research
Lake Worth, Florida, 33461
May Grant OB/GYN
Lancaster, Pennsylvania, 17601
Square Care Health
New Hyde Park, New York, 11040
Northwell Health
New Hyde Park, New York, 11042
About this study
The objective of this project is to validate the sensitivity, specificity, positive predictive value and negative predictive values of the AMRA blood test for assessing risk of cancer in women at high risk for ovarian cancer, due to the presence of a symptomatic adnexal mass.
- Conditions
- Adnexal Mass
- Being tested
- OVAnex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OVAnexDevice
OVAnex is a multivarite index assay assessing ovarian cancer risk
| Study group | Role | What they receive |
|---|---|---|
| Group A | Symptomatic with adnexal mass Receives: Device: OVAnex | |
| Group B | Asymptomatic with adnexal mass Receives: Device: OVAnex | |
| Group C | Women with a predisposition in developing ovarian cancer due to a positive, pathogenic variant Receives: Device: OVAnex |
What is being measured
The primary outcome is the main question the study is designed to answer.
OVAnex
OVAnex is a multivariate index assay assessing ovarian cancer risk. The Ovanex MIA uses seven biomarkers with a stepwise algorithm to generate a risk score which ranges from 0 to 20.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start25 Jun 2020
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Why it stopped: cohort C looked at feasibility of genetics \& protein to evaluate risk with a family hx of cancer or associated variant. Since few patients show these factors, this approach would not yield sufficient information to make inferences
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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 721 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aspira Women's Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Todd Pappas, PhD, Principal investigator, Aspira Women's Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487405
- Sponsor's protocol ID
- 04-2019
- Acronym
- OVAnex
- Status last verified
- Dec 2023
- First submitted
- 10 Jul 2020
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- 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 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multivariate Index Assay for Ovarian Cancer Risk Assessment in Women With Adnexal Mass and High-Risk Germline Variants
- ClinicalTrials.gov ID
- NCT04487405
- Acronym / sponsor ID
- OVAnex / 04-2019
- Conditions
- Adnexal Mass
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: cohort C looked at feasibility of genetics \& protein to evaluate risk with a family hx of cancer or associated variant. Since few patients show these factors, this approach would not yield sufficient information to make inferences
- Enrolment
- 721 participants (actual)
- Lead sponsor
- Aspira Women's HealthIndustry (pharma, biotech, devices)
- Study start
- 25 Jun 2020 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 27 Jul 2020 (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 objective of this project is to validate the sensitivity, specificity, positive predictive value and negative predictive values of the AMRA blood test for assessing risk of cancer in women at high risk for ovarian cancer, due to the presence of a symptomatic adnexal mass.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Device: OVAnexSymptomatic with adnexal mass |
| Group B | – | Device: OVAnexAsymptomatic with adnexal mass |
| Group C | – | Device: OVAnexWomen with a predisposition in developing ovarian cancer due to a positive, pathogenic variant |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult women with an ovarian adnexal mass, or in follow up due to the presence of BRCA1/2 and other germline DNA variants.
Key inclusion criteria (2 listed)
- Female patient, 18 years of age or older diagnosed with an ovarian adnexal mass, or in follow-up due to the presence of BRCA1/2 and other germline DNA variants.
- Patient reviewed, understood, and provided the PI with written informed consent to allow blood specimen to be used for research and release of medical information.
Key exclusion criteria (2 listed)
- Patient is less than 18 years of age
- Patient is not being treated in the U.S.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OVAnexOVAnex is a multivarite index assay assessing ovarian cancer risk | Device | Group A, Group B, Group C |
Primary outcome
OVAnex
Time frame: 12 months
OVAnex is a multivariate index assay assessing ovarian cancer risk. The Ovanex MIA uses seven biomarkers with a stepwise algorithm to generate a risk score which ranges from 0 to 20.
Results and safety
The study was stopped early (reason given: cohort C looked at feasibility of genetics \& protein to evaluate risk with a family hx of cancer or associated variant. Since few patients show these factors, this approach would not yield sufficient information to make inferences). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- 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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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.
Todd Pappas, PhD principal investigator
Aspira Women's Health
9 sites 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 Aspira Women's Health at 9 sites 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 2 inclusion and 2 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 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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: cohort C looked at feasibility of genetics \& protein to evaluate risk with a family hx of cancer or associated variant. Since few patients show these factors, this approach would not yield sufficient information to make inferences). 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?
OVAnex (time frame: 12 months). 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 26 Dec 2023.