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Trial record 1 of 1 for:    NCT02355587
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Five Year Study to Track Use of DecisionDX-Melanoma Test in Patients With Cutaneous Melanoma and Associated Patient Outcomes (EXPAND)

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ClinicalTrials.gov Identifier: NCT02355587
Recruitment Status : Terminated (Study goals were met with smaller that expected study cohort. Last patient completed the study June 201)
First Posted : February 4, 2015
Last Update Posted : October 8, 2021
Information provided by (Responsible Party):
Castle Biosciences Incorporated

Brief Summary:

The EXPAND Registry Study follows patients with cutaneous melanoma who have had the DecisionDx-Melanoma gene expression assay performed as part of their clinical care. Data will be collected through review of medical records from clinical visits with physician.

The purpose is to document the clinical application of results obtained from the DecisionDx- Melanoma multi-gene assay and to track outcomes of patients for whom DecisionDx-Melanoma testing has been completed. Additionally the study will assess the health economic impact of DecisionDx-Melanoma testing as it relates to the Melanoma population.

Condition or disease
Cutaneous Melanoma

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Study Type : Observational [Patient Registry]
Actual Enrollment : 72 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: An Open, 5-year Registry Study to Track Clinical Application of DecisionDx-Melanoma Gene Expression Profile Assay Results and Associated Patient Outcomes
Actual Study Start Date : March 2014
Actual Primary Completion Date : July 2021
Actual Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Melanoma

Primary Outcome Measures :
  1. Adjusted surveillance regimen [ Time Frame: upon receipt DecisionDX-Melanoma results received and every 6 months thereafter ]
    • Relaxed surveillance for the low risk group;
    • Increased vigilance for early detection in the high risk group.

Secondary Outcome Measures :
  1. Referral for sentinel lymph node interrogation in the high risk group in thin melanomas. [ Time Frame: Upon receipt DecisionDx-Melanoma results ]

Other Outcome Measures:
  1. Early referral to medical oncologist for high risk patients. [ Time Frame: Upon Receipt DecisionDx-Melanoma results ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with cutaneous melanoma for whom DecisionDx-Melanoma testing is to be clinically performed.

Inclusion Criteria:

  • Patients diagnosed with melanoma and determined, by their physician, to be appropriate for DecisionDx-Melanoma testing and who have successful results available to the investigator are eligible for registration
  • Patients enrolled should be reasonably able to follow-up with the enrolling physician at regular intervals for assessment of outcome data.
  • 16 Years and older

Exclusion Criteria:

  • Less than 16 Years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355587

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United States, California
Sutter Health
Santa Rosa, California, United States, 95403
United States, Maryland
Elizabeth Liotta Dermatology
Frederick, Maryland, United States, 21702
United States, Nevada
University of Nevada
Las Vegas, Nevada, United States, 89102
United States, South Carolina
South Carolina Skin Care Center
Greenville, South Carolina, United States, 29607
Sponsors and Collaborators
Castle Biosciences Incorporated
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Principal Investigator: Robert Cook, PhD Castle Biosciences Inc.
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Castle Biosciences Incorporated
ClinicalTrials.gov Identifier: NCT02355587    
Other Study ID Numbers: EXPAND_1_Protocol- Amendment 1
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Castle Biosciences Incorporated:
cutaneous melanoma
Additional relevant MeSH terms:
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Skin Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Neoplasms by Site
Skin Diseases