Clinical trial · Observational
Five Year Study to Track Use of DecisionDX-Melanoma Test in Patients With Cutaneous Melanoma and Associated Patient Outcomes
An Open, 5-year Registry Study to Track Clinical Application of DecisionDx-Melanoma Gene Expression Profile Assay Results and Associated Patient Outcomes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study goals were met with smaller that expected study cohort. Last patient completed the study June 201
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous Melanoma | Cutaneous Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Adjusted surveillance regimen
- timeFrame
- upon receipt DecisionDX-Melanoma results received and every 6 months thereafter
- description
- * Relaxed surveillance for the low risk group; * Increased vigilance for early detection in the high risk group.
Secondary outcomes (1)
- measure
- Referral for sentinel lymph node interrogation in the high risk group in thin melanomas.
- timeFrame
- Upon receipt DecisionDx-Melanoma results
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDWhitman 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. PMID 34568719
- DERIVEDHsueh 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. PMID 34036233