Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT02355587
Recruitment Status : Active, not recruiting
First Posted : February 4, 2015
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Castle Biosciences Incorporated

Tracking Information
First Submitted Date December 18, 2014
First Posted Date February 4, 2015
Last Update Posted Date June 24, 2020
Study Start Date March 2014
Estimated Primary Completion Date February 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 3, 2015)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 3, 2015)
Referral for sentinel lymph node interrogation in the high risk group in thin melanomas. [ Time Frame: Upon receipt DecisionDx-Melanoma results ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 3, 2015)
Early referral to medical oncologist for high risk patients. [ Time Frame: Upon Receipt DecisionDx-Melanoma results ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Five Year Study to Track Use of DecisionDX-Melanoma Test in Patients With Cutaneous Melanoma and Associated Patient Outcomes
Official Title An Open, 5-year Registry Study to Track Clinical Application of DecisionDx-Melanoma Gene Expression Profile Assay Results and Associated Patient Outcomes
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.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with cutaneous melanoma for whom DecisionDx-Melanoma testing is to be clinically performed.
Condition Cutaneous Melanoma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: February 3, 2015)
5000
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2024
Estimated Primary Completion Date February 2024   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02355587
Other Study ID Numbers EXPAND_1_Protocol- Amendment 1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Castle Biosciences Incorporated
Study Sponsor Castle Biosciences Incorporated
Collaborators Not Provided
Investigators
Principal Investigator: Robert Cook, PhD Castle Biosciences Inc.
PRS Account Castle Biosciences Incorporated
Verification Date June 2020