NCT02355587

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2014

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 4, 2015

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

October 8, 2021

Status Verified

September 1, 2021

Enrollment Period

7.3 years

First QC Date

December 18, 2014

Last Update Submit

October 1, 2021

Conditions

Cutaneous Melanoma

Keywords

melanomacutaneous melanomaDecisionDx-Melanoma

Outcome Measures

Primary Outcomes (1)

  • Adjusted surveillance regimen

    * Relaxed surveillance for the low risk group; * Increased vigilance for early detection in the high risk group.

    upon receipt DecisionDX-Melanoma results received and every 6 months thereafter

Secondary Outcomes (1)

  • Referral for sentinel lymph node interrogation in the high risk group in thin melanomas.

    Upon receipt DecisionDx-Melanoma results

Other Outcomes (1)

  • Early referral to medical oncologist for high risk patients.

    Upon Receipt DecisionDx-Melanoma results

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with cutaneous melanoma for whom DecisionDx-Melanoma testing is to be clinically performed.

You may qualify if:

  • 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.
  • Years and older

You may not qualify if:

  • Less than 16 Years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Sutter Health

Santa Rosa, California, 95403, United States

Location

Elizabeth Liotta Dermatology

Frederick, Maryland, 21702, United States

Location

University of Nevada

Las Vegas, Nevada, 89102, United States

Location

South Carolina Skin Care Center

Greenville, South Carolina, 29607, United States

Location

Related Publications (2)

  • 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.

    PMID: 34568719DERIVED

  • 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.

    PMID: 34036233DERIVED

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Robert Cook, PhD

    Castle Biosciences Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2014

First Posted

February 4, 2015

Study Start

March 1, 2014

Primary Completion

July 1, 2021

Study Completion

July 31, 2021

Last Updated

October 8, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(4)