5 Year Registry Study to Track Clinical Application of DecisionDx-UM Assay Results and Associated Patient Outcomes
CLEAR
CLEAR Registry Study: An Open, 5-year Registry Study to Track Clinical Application of DecisionDx-UM Multigene Assay Results and Associated Patient Outcomes.
1 other identifier
observational
93
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2010
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 13, 2015
CompletedFirst Posted
Study publicly available on registry
March 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedMay 16, 2022
May 1, 2022
12.1 years
February 13, 2015
May 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
documentation of clinical application of results obtained from DecisionDx-UM multi-gene assay
Physician treatment plan with regards to surveillance regimen as well as treatment referral pattern
Approximately 3-6 weeks after biopsy of uveal tumor
Time to metastasis
Patients followed for up to 10 years, measurement for metastatic event performed at 6 month intervals
Secondary Outcomes (1)
changes in health care costs
Patients followed for up to 10 years at 6 month intervals
Eligibility Criteria
Patients diagnosed with uveal melanoma and determined by their treating physician to be appropriate for DecisionDx-UM testing.
You may qualify if:
- 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
You may not qualify if:
- Patients with any other form of cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Plasseraud 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: 27446211DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Cook, PhD
Castle Biosciences Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2015
First Posted
March 3, 2015
Study Start
March 1, 2010
Primary Completion
April 1, 2022
Study Completion
April 1, 2022
Last Updated
May 16, 2022
Record last verified: 2022-05