An observational study in Melanoma Detection, sponsored by DermTech. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2021-03-26.
Sponsored by DermTech · Observational
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 who had, or will have a DermTech Pigmented Lesion Assay completed on a lesion suspected of being melanoma are eligible for the study. Based on historical data, an expected melanoma rate of approximately 5% to 10% is anticipated.
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.
3,006 studies on the registry are indexed under Melanoma; 520 are open to participants now.
This study's enrollment of 323 is above the median of 182 across 438 observational studies indexed under Melanoma.
Browse Melanoma studies →DermTech is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Subjects who had a DermTech PLA completed on a lesion suspected of being melanoma are eligible for the study. Based on historical data, an expected melanoma positivity rate of 5%-10% is anticipated.
Exclusion Criteria:
PLA- initially and repeat testing 1-2 years later
Other: Repeat Testing
Not eligible for the study
Repeat Testing with the PLA will be conducted
Proportion of subjects without surgical biopsy
The proportion of subjects who exit the study without surgical biopsy out to approximately up to 24 months ± SOC
Time frame: approximately up to 24 months
Results of PLA results compared to biopsy
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.
Time frame: approximately up to 24 months
Plan to share: No — All samples received have been de-identified with a study and subject specific number.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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