Clinical trial NCT02355574: 5-year Study to Track Clinical Application of DecisionDx-Melanoma Gene Expression Profile Assay Results
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 type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cutaneous Melanoma
Keywords: melanoma
cutaneous melanoma
DecisionDx-Melanoma
Lead sponsor: Castle Biosciences Incorporated
Sponsor class: INDUSTRY
First posted: 2015-02-04
Enrollment: 301
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cutaneous melanoma for whom DecisionDx-Melanoma testing is to be clinically performed.

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.


Eligibility 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

Primary outcomes:
measure: Adjusted surveillance regimen
timeFrame: upon receipt DecisionDX-Melanoma results received and every 6 months thereafter
Secondary outcomes:
measure: Referral for sentinel lymph node interrogation in the high risk group in thin melanomas.
timeFrame: Upon receipt DecisionDx-Melanoma results
Other outcomes:
measure: Early referral to medical oncologist for high risk patients.
timeFrame: Upon Receipt DecisionDx-Melanoma results
Locations:
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
Study officials:
affiliation: Castle Biosciences Inc.
name: Robert Cook, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.