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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
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Symptomatic with adnexal mass |
| |
| Group B | Asymptomatic with adnexal mass |
| |
| Group C | Women with a predisposition in developing ovarian cancer due to a positive, pathogenic variant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OVAnex | Device | OVAnex is a multivarite index assay assessing ovarian cancer risk |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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Adult women with an ovarian adnexal mass, or in follow up due to the presence of BRCA1/2 and other germline DNA variants.
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| Name | Affiliation | Role |
|---|---|---|
| Todd Pappas, PhD | Aspira Women's Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Health Arizona | Chandler | Arizona | 85224 | United States | ||
| Altus Research |
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Serum
| Lake Worth |
| Florida |
| 33461 |
| United States |
| MidTown OBGYN | Columbus | Georgia | 31901 | United States |
| Premier OBGYN of Minnesota | Eden Prairie | Minnesota | 55344 | United States |
| Square Care Health | New Hyde Park | New York | 11040 | United States |
| Northwell Health | New Hyde Park | New York | 11042 | United States |
| Seven Hills Clinical Research Group | Cincinnati | Ohio | 45211 | United States |
| May Grant OB/GYN | Lancaster | Pennsylvania | 17601 | United States |
| Hill Country OBGYN Associates | Austin | Texas | 78748 | United States |