Clinical trial · Observational
Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection
NCT04668521CI-TRIAL-00072533OVA360terminatedClinicalTrials.gov clinicaltrialsProvenance
- 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 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
Conditions (4)
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 | — |
| Germline BRCA1 Gene Mutation | — | UNRESOLVED | — |
| Germline BRCA2 Gene Mutation | — | UNRESOLVED | — |
| Hereditary Breast and Ovarian Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OVA360 | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- COHORT A
- description
- Women with a pelvic mass, symptomatic or asymptomatic.
- interventionNames
- Other: OVA360
- label
- COHORT B
- description
- Women diagnosed with a pelvis mass undergoing genetic testing through our commercial offering.
- interventionNames
- Other: OVA360
- label
- COHORT C
- description
- 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.
- interventionNames
- Other: OVA360
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Key inclusion criteria: * 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 * 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. Exclusion Criteria: * n/a
References
Publications (0)
Data not yet available
No reference posted for this study.