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Trial record 1 of 1 for:    NCT02355574
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5-year Study to Track Clinical Application of DecisionDx-Melanoma Gene Expression Profile Assay Results (INTEGRATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02355574
Recruitment Status : Active, not recruiting
First Posted : February 4, 2015
Last Update Posted : June 24, 2020
Information provided by (Responsible Party):
Castle Biosciences Incorporated

Brief Summary:

The INTEGRATE Registry Study follows patients with cutaneous melanoma who have had the DecisionDx-Melanoma gene expression assay performed. 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]
Estimated Enrollment : 1672 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: An Ongoing, 5-year Post Market Study to Track Clinical Application of DecisionDx-Melanoma Gene Expression Profile (GEP) Assay Results and the Impact on Patient Outcomes and Health Economics
Study Start Date : March 2014
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : June 2024

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 ]
    referral to SLNB in HR melanoma

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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 identifier (NCT number): NCT02355574

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United States, Georgia
Northside Hospital
Atlanta, Georgia, United States, 30342
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Missouri
Saint Louis University
Saint Louis, Missouri, United States, 63103
Sponsors and Collaborators
Castle Biosciences Incorporated
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Principal Investigator: Robert Cook, PhD Castle Biosciences Inc.
Additional Information:

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Responsible Party: Castle Biosciences Incorporated Identifier: NCT02355574    
Other Study ID Numbers: INTEGRATE_1_Protocol
First Posted: February 4, 2015    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020
Keywords provided by Castle Biosciences Incorporated:
cutaneous melanoma
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas