Five Year Study to Track Use of DecisionDX-Melanoma Test in Patients With Cutaneous Melanoma and Associated Patient Outcomes

NCT ID: NCT02355587

Last Updated: 2021-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2021-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cutaneous Melanoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Castle Biosciences Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert Cook, PhD

Role: PRINCIPAL_INVESTIGATOR

Castle Biosciences Inc.

Locations

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Sutter Health

Santa Rosa, California, United States

Site Status

Elizabeth Liotta Dermatology

Frederick, Maryland, United States

Site Status

University of Nevada

Las Vegas, Nevada, United States

Site Status

South Carolina Skin Care Center

Greenville, South Carolina, United States

Site Status

Countries

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United States

References

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Whitman ED, Koshenkov VP, Gastman BR, Lewis D, Hsueh EC, Pak H, Trezona TP, Davidson RS, McPhee M, Guenther JM, Toomey P, Smith FO, Beitsch PD, Lewis JM, Ward A, Young SE, Shah PK, Quick AP, Martin BJ, Zolochevska O, Covington KR, Monzon FA, Goldberg MS, Cook RW, Fleming MD, Hyams DM, Vetto JT. Integrating 31-Gene Expression Profiling With Clinicopathologic Features to Optimize Cutaneous Melanoma Sentinel Lymph Node Metastasis Prediction. JCO Precis Oncol. 2021 Sep 13;5:PO.21.00162. doi: 10.1200/PO.21.00162. eCollection 2021.

Reference Type DERIVED
PMID: 34568719 (View on PubMed)

Hsueh EC, DeBloom JR, Lee JH, Sussman JJ, Covington KR, Caruso HG, Quick AP, Cook RW, Slingluff CL Jr, McMasters KM. Long-Term Outcomes in a Multicenter, Prospective Cohort Evaluating the Prognostic 31-Gene Expression Profile for Cutaneous Melanoma. JCO Precis Oncol. 2021 Apr 6;5:PO.20.00119. doi: 10.1200/PO.20.00119. eCollection 2021.

Reference Type DERIVED
PMID: 34036233 (View on PubMed)

Other Identifiers

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EXPAND_1_Protocol- Amendment 1

Identifier Type: -

Identifier Source: org_study_id

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