5 Year Registry Study to Track Clinical Application of DecisionDx-UM Assay Results and Associated Patient Outcomes

Uveal Melanoma Clinical Trial

— CLEAR  

Official title:

CLEAR Registry Study: An Open, 5-year Registry Study to Track Clinical Application of DecisionDx-UM Multigene Assay Results and Associated Patient Outcomes.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02376920
• Other study ID #: 2-01
• Status: Completed
• Start date: March 2010
• Est. completion date: April 2022

Study information

• Verified date: May 2022
• Source: Castle Biosciences Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma
• Uveal Melanoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Castle Biosciences Incorporated

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Time to metastasis		Patients followed for up to 10 years, measurement for metastatic event performed at 6 month intervals
Secondary	changes in health care costs	review of health care testing (imaging, laboratory testing) to determine changes in health care costs resulting from DecisionDx-UM testing	Patients followed for up to 10 years at 6 month intervals