Adnexal MassOVA360NCT04668521
Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection
An observational study of Adnexal Mass and Germline BRCA1 Gene Mutation, run by Aspira Women's Health at 1 site in United States.
Trial summary
The objective of this project is to validate a next-generation assay that utilizes both the protein biomarkers of our already established ovarian cancer risk assessment combined with a molecular profile in both germline and early somatic detection. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adnexal Mass, Germline BRCA1 Gene Mutation, Germline BRCA2 Gene Mutation
- What is being tested?
- OVA360
- How many people
- 215 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women with or without a pelvic mass.
Who may be able to join
- Female subject
- 18 years of age or older
- Cohort A specific inclusion criteria:
- Diagnosed with a pelvic mass
- Cohort B specific inclusion criteria:
- Diagnosed with a pelvic mass
Show all 9Show fewer
- Undergoing genetic testing through our commercial offering
- Cohort C specific inclusion criteria:
- Subject must not have an identifiable adnexal mass and may, or may not, have a family history or a known familial genetic abnormality (germ line or identified in family cancer i.e. somatic DNA mutation) associated with ovarian cancer.
Who cannot join
- n/a
Trial locations and contacts
1 site in 1 country.
About this study
The objective of this project is to validate a next-generation assay that utilizes both the protein biomarkers of our already established ovarian cancer risk assessment combined with a molecular profile in both germline and early somatic detection.
- Conditions
- Adnexal Mass, Germline BRCA1 Gene Mutation, Germline BRCA2 Gene Mutation, Hereditary Breast and Ovarian Cancer
- Being tested
- OVA360
- Medical subject headings
- Hereditary Breast and Ovarian Cancer Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OVA360Other
Multifactorial Risk Assessment for Breast \& Ovarian Cancer Risk Detection
| Study group | Role | What they receive |
|---|---|---|
| COHORT A | Women with a pelvic mass, symptomatic or asymptomatic. Receives: Other: OVA360 | |
| COHORT B | Women diagnosed with a pelvis mass undergoing genetic testing through our commercial offering. Receives: Other: OVA360 | |
| COHORT C | Subject must not have an identifiable adnexal mass and may, or may not, have a family history or a known familial genetic abnormality (germ line or identified in family cancer i.e. somatic DNA mutation) associated with ovarian cancer. Receives: Other: OVA360 |
What is being measured
The primary outcome is the main question the study is designed to answer.
OVA360
Identify the molecular key driver of Ovarian cancer and develop a diagnostic test for early Ovarian cancer detection
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 posted16 Dec 2020
- Study start4 May 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 215 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
- NCT04668521
- Sponsor's protocol ID
- 05-2019
- Acronym
- OVA360
- Status last verified
- Dec 2023
- First submitted
- 9 Dec 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
- Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection
- ClinicalTrials.gov ID
- NCT04668521
- Acronym / sponsor ID
- OVA360 / 05-2019
- Conditions
- Adnexal Mass, Germline BRCA1 Gene Mutation, Germline BRCA2 Gene Mutation, Hereditary Breast and Ovarian Cancer
- 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
- 215 participants (actual)
- Lead sponsor
- Aspira Women's HealthIndustry (pharma, biotech, devices)
- Study start
- 4 May 2020 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 16 Dec 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 a next-generation assay that utilizes both the protein biomarkers of our already established ovarian cancer risk assessment combined with a molecular profile in both germline and early somatic detection.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COHORT A | – | Other: OVA360Women with a pelvic mass, symptomatic or asymptomatic. |
| COHORT B | – | Other: OVA360Women diagnosed with a pelvis mass undergoing genetic testing through our commercial offering. |
| COHORT C | – | Other: OVA360Subject must not have an identifiable adnexal mass and may, or may not, have a family history or a known familial genetic abnormality (germ line or identified in family cancer i.e. somatic DNA mutation) associated with ovarian cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women with or without a pelvic mass.
Key inclusion criteria (9 listed)
- Female subject
- 18 years of age or older
- Diagnosed with a pelvic mass
- Diagnosed with a pelvic mass
- Undergoing genetic testing through our commercial offering
Key exclusion criteria (1 listed)
- n/a
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 |
|---|---|---|
| OVA360Multifactorial Risk Assessment for Breast \& Ovarian Cancer Risk Detection | Other | COHORT A, COHORT B, COHORT C |
Primary outcome
OVA360
Time frame: 12 months
Identify the molecular key driver of Ovarian cancer and develop a diagnostic test for early Ovarian cancer detection
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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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
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 and Germline BRCA1 Gene Mutation, run by Aspira Women's Health 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 9 inclusion and 1 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 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: 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?
OVA360 (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.