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

Castle Biosciences Incorporated

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.

General Publications

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.

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