DermTech's Non-Invasive Pigmented Lesion Assay to Detect and Track Lesions for Suspected Melanoma and to Determine Outcomes for up to 2 Years
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|ClinicalTrials.gov Identifier: NCT04563949|
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : September 25, 2020
|Condition or disease||Intervention/treatment|
|Melanoma Detection||Diagnostic Test: DermTech PLA Assay|
This is a multi-center, sample collection study to follow clinically suspicious lesions to determine the outcome including surgical biopsy, removal, monitoring, etc. for up to 2 years after lesion identification.
Subjects will be consented and enter the trial to have their suspicious lesion(s), biopsied via DermTech's adhesive patch biopsy and assessed with DermTech's non-invasive PLA, and followed up to 2 years per standard of care. Lesions must be photographed and/or the site of the lesion anatomically defined to permit follow-up of the lesion(s) and lesional site(s) during future visits.
Subjects will be followed per standard of care for lesion biopsy, excision, treatment and/or monitoring. Other than DermTech's non-invasive PLA of the lesion(s) no other study procedures will be performed and subjects will be treated according to the standard of care. The subject's medical management team should use standard of care, visual assessment changes (i.e., "ABCDE") and physician judgment for suspicious lesion characterization and monitoring when planning the subject's course of treatment.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Clinical Practice Utility Study to Assess DermTech's Non-Invasive Pigmented Lesion Assay to Detect and Track Lesions for Suspected Melanoma and to Determine Outcomes for up to 2 Years|
|Actual Study Start Date :||November 16, 2017|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||October 30, 2020|
- Diagnostic Test: DermTech PLA Assay
PLA assay measuring PRAME and LINC for gene expressionOther Name: Pigmented Lesion Assay (PLA)
- Proportion of subjects without surgical biopsy [ Time Frame: approximately up to 24 months ]The proportion of subjects who exit the study without surgical biopsy out to approximately up to 24 months ± SOC
- Results of PLA results compared to biopsy [ Time Frame: approximately up to 24 months ]Expression of genes during the 2-year study. The association of gene expression and algorithm values with melanoma versus non-melanoma will be examined using clinical performance indicators negative predictive value with their respective 95th percentile confidence intervals.
Biospecimen Retention: Samples Without DNA
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): NCT04563949