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Completed

NCT Number: NCT02376920

5 Year Registry Study to Track Clinical Application of DecisionDx-UM 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.

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Key information

Conditions

Uveal Melanoma Eye Diseases Eye Neoplasms Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Tumors Nevi and Melanomas Uveal Diseases Uveal Neoplasms

Age range

16 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. Time to metastasis

    Time frame: Patients followed for up to 10 years, measurement for metastatic event performed at 6 month intervals

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Castle Biosciences Incorporated

Industry

Registry information

Official study title

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

Acronym: CLEAR

Important dates

Study start
2010
Primary completion
2022
Study completion
2022
First posted
Mar 3, 2015
Registry last updated
May 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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