Clinical trial · Observational
A Multivariate Index Assay for Ovarian Cancer Risk Assessment in Women With Adnexal Mass and High-Risk Germline Variants
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adnexal Mass | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OVAnex | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Group A
- description
- Symptomatic with adnexal mass
- interventionNames
- Device: OVAnex
- label
- Group B
- description
- Asymptomatic with adnexal mass
- interventionNames
- Device: OVAnex
- label
- Group C
- description
- Women with a predisposition in developing ovarian cancer due to a positive, pathogenic variant
- interventionNames
- Device: OVAnex
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * Patient is less than 18 years of age * Patient is not being treated in the U.S.
References
Publications (0)
Data not yet available