Clinical trial · Observational
5 Year Registry Study to Track Clinical Application of DecisionDx-UM Assay Results and Associated Patient Outcomes
CLEAR Registry Study: An Open, 5-year Registry Study to Track Clinical Application of DecisionDx-UM Multigene Assay Results and Associated Patient Outcomes.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Uveal Melanoma is a rare cancer with approximately 3,000 cases diagnosed in the US every year. Nearly half of these experience spread of their cancer outside the eye. The DecisionDx-UM gene expression test classifies an individual's tumor as low risk (class 1) or high risk (class 2) of spreading. This study is being done to collect information about how physicians are using the DecisionDx-UM results to design individual treatment plans. It will also track outcomes or the uveal melanoma population that received DecisionDx-UM testing.
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 |
|---|---|---|---|
| Uveal Melanoma | Uveal Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- documentation of clinical application of results obtained from DecisionDx-UM multi-gene assay
- timeFrame
- Approximately 3-6 weeks after biopsy of uveal tumor
- description
- Physician treatment plan with regards to surveillance regimen as well as treatment referral pattern
- measure
- Time to metastasis
- timeFrame
- Patients followed for up to 10 years, measurement for metastatic event performed at 6 month intervals
Secondary outcomes (1)
- measure
- changes in health care costs
- timeFrame
- Patients followed for up to 10 years at 6 month intervals
- description
- review of health care testing (imaging, laboratory testing) to determine changes in health care costs resulting from DecisionDx-UM testing
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with a diagnosis of Uveal Melanoma * Patients whose physician deems them appropriate for DecisionDx-UM testing * Patients reasonably able to follow up with enrolling physician at regular intervals for assessment of outcome data Exclusion Criteria: * Patients with any other form of cancer
References
Publications (1)
- DERIVEDPlasseraud KM, Cook RW, Tsai T, Shildkrot Y, Middlebrook B, Maetzold D, Wilkinson J, Stone J, Johnson C, Oelschlager K, Aaberg TM. Clinical Performance and Management Outcomes with the DecisionDx-UM Gene Expression Profile Test in a Prospective Multicenter Study. J Oncol. 2016;2016:5325762. doi: 10.1155/2016/5325762. Epub 2016 Jun 30. PMID 27446211