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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02376920

Acronym

CLEAR

Enrollment

Registered

2015-03-03

Start date

2010-03-31

Completion date

2022-04-30

Last updated

2022-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uveal Melanoma

Keywords

occular melanoma, melanoma of eye, DecisionDx-UM

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
documentation of clinical application of results obtained from DecisionDx-UM multi-gene assay	Approximately 3-6 weeks after biopsy of uveal tumor	Physician treatment plan with regards to surveillance regimen as well as treatment referral pattern
Time to metastasis	Patients followed for up to 10 years, measurement for metastatic event performed at 6 month intervals	—

Secondary

Measure	Time frame	Description
changes in health care costs	Patients followed for up to 10 years at 6 month intervals	review of health care testing (imaging, laboratory testing) to determine changes in health care costs resulting from DecisionDx-UM testing

Outcome results