A Multivariate Index Assay for Ovarian Cancer Risk Assessment in Women With Adnexal Mass and High-Risk Germline Variants
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
Key facts
- Where
- Austin, Chandler, Cincinnati, Columbus, Eden Prairie, Lake Worth, Lancaster, and New Hyde Park, United StatesSee the 9 sites
Where in United States
- Hill Country OBGYN AssociatesAustin, United StatesNo longer taking part
- Women's Health ArizonaChandler, United StatesNo longer taking part
- Seven Hills Clinical Research GroupCincinnati, United StatesNo longer taking part
- MidTown OBGYNColumbus, United StatesNo longer taking part
- Premier OBGYN of MinnesotaEden Prairie, United StatesNo longer taking part
- Altus ResearchLake Worth, United StatesNo longer taking part
- May Grant OB/GYNLancaster, United StatesNo longer taking part
- Northwell HealthNew Hyde Park, United StatesNo longer taking part
- Square Care HealthNew Hyde Park, United StatesNo longer taking part
Trial details
- Who runs it
- Aspira Women's Health
- Trial code
- NCT04487405
- Record updated
- 26 December 2023
- Original description
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 full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Patient is less than 18 years of age; Patient is not being treated in the U.S.