DermTech's Non-Invasive Pigmented Lesion Assay to Detect and Track Lesions for Suspected Melanoma and to Determine Outcomes for up to 2 Years

Completed

Conditions studied: Melanoma Detection

In brief

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.

Key facts

Study ID

NCT04563949

Run by

DermTech

People needed

323

Starts

2017-11-16

Expected to finish

2020-12-15

Last updated by the study team

2021-03-26

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and females the treating physician chose to use the PLA on;
• Presence of a lesion(s) that is suspicious for melanoma and a candidate for surgical biopsy that was previously biopsied with DermTech's adhesive patch biopsy and assessed via PLA;
• Willing to permit subsequent PLA assays to be performed on suspicious lesions;
• Willing to follow standard of care treatment for the lesion(s) as determined by the treating physician;
• Subjects must be able to complete study visits required by the protocol (subject is not planning to relocate or travel thus prevent attendance at future study visits; and
• Willing to provide informed consent to participate in this trial.

You may not qualify if…

• Has confirmed melanoma or a suspicious lesion that required a surgical biopsy or excision prior to the intial PLA on that lesion of interest;
• Has an ulcerated or bleeding lesion that could cofound the PLA results;
• Has a suspicious lesion(s) in an area that was previously surgically biopsied;
• The lesion(s) is on the palms, mucosal surface, or other area where adhesive patch biopsies cannot be performed;
• Has an allergy to tape or latex rubber;
• Receipt of any investigational drug therapy within four weeks of study enrollment, or concurrent participation in another interventional clinical study deemed by the treating physician to potentially influence this study; and
• Documented substance abuse, any other significant medical condition or laboratory result that would indicate an unreasonable risk to the subject or potential interference with study procedures, or would negatively affect the patient's reliability and compliance with the study schedule of events. -

Where it is running

• West Dermatology — San Diego, California, United States

Full record on ClinicalTrials.gov

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