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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 : Active, not recruiting
First Posted : February 4, 2015
Last Update Posted : February 27, 2017
Sponsor:
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

Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 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
Study Start Date : March 2014
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : February 2024

Resource links provided by the National Library of Medicine

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.
Criteria

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


Locations
United States, California
Sutter Health
Santa Rosa, California, United States, 95403
United States, Maryland
Elizabeth Liotta Dermatology
Fredrick, 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
Investigators
Principal Investigator: Robert Cook, PhD Castle Biosciences Inc.

Responsible Party: Castle Biosciences Incorporated
ClinicalTrials.gov Identifier: NCT02355587     History of Changes
Other Study ID Numbers: EXPAND_1_Protocol- Amendment 1
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017

Keywords provided by Castle Biosciences Incorporated:
melanoma
cutaneous melanoma
DecisionDx-Melanoma

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas