Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-03-01 @ 4:13 PM
Study NCT ID:
NCT02376920
Status:
COMPLETED
Last Update Posted:
2022-05-16
First Post:
2015-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
5 Year Registry Study to Track Clinical Application of DecisionDx-UM Assay Results and Associated Patient Outcomes
Sponsor:
Castle Biosciences Incorporated
Organization:
Study Overview
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.
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CLEAR
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: