5-year Study to Track Clinical Application of DecisionDx-Melanoma Gene Expression Profile Assay Results (INTEGRATE)
|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: NCT02355574|
Recruitment Status : Active, not recruiting
First Posted : February 4, 2015
Last Update Posted : February 27, 2017
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.
|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||1672 participants|
|Target Follow-Up Duration:||10 Years|
|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 Start Date :||March 2014|
|Estimated Primary Completion Date :||February 2024|
|Estimated Study Completion Date :||June 2024|
- 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.
- Referral for sentinel lymph node interrogation in the high risk group in thin melanomas. [ Time Frame: Upon receipt DecisionDx-Melanoma results ]
- Early referral to medical oncologist for high risk patients. [ Time Frame: Upon Receipt DecisionDx-Melanoma results ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02355574
|United States, Georgia|
|Atlanta, Georgia, United States, 30342|
|United States, Kentucky|
|University of Louisville|
|Louisville, Kentucky, United States, 40202|
|United States, Missouri|
|Saint Louis University|
|St. Louis, Missouri, United States, 63103|
|Principal Investigator:||Robert Cook, PhD||Castle Biosciences Inc.|