5 Year Registry Study to Track Clinical Application of DecisionDx-UM Assay Results and Associated Patient Outcomes (CLEAR)
May 13, 2022 updated by: Castle Biosciences Incorporated
CLEAR Registry Study: An Open, 5-year Registry Study to Track Clinical Application of DecisionDx-UM Multigene Assay Results and Associated Patient Outcomes.
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
93
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients diagnosed with uveal melanoma and determined by their treating physician to be appropriate for DecisionDx-UM testing.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
documentation of clinical application of results obtained from DecisionDx-UM multi-gene assay
Time Frame: Approximately 3-6 weeks after biopsy of uveal tumor
|
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
Time Frame: Patients followed for up to 10 years, measurement for metastatic event performed at 6 month intervals
|
Patients followed for up to 10 years, measurement for metastatic event performed at 6 month intervals
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
changes in health care costs
Time Frame: 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
|
Patients followed for up to 10 years at 6 month intervals
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Robert Cook, PhD, Castle Biosciences Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
April 1, 2022
Study Completion (Actual)
April 1, 2022
Study Registration Dates
First Submitted
February 13, 2015
First Submitted That Met QC Criteria
March 2, 2015
First Posted (Estimate)
March 3, 2015
Study Record Updates
Last Update Posted (Actual)
May 16, 2022
Last Update Submitted That Met QC Criteria
May 13, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.