Sample Collection Study in Patients With Suspected Melanoma Utilizing DermTech's Non-invasive Adhesive Patch Biopsy Kits

Completed

Conditions studied: Melanoma (Skin), Pigmented Skin, Nevus

In brief

A multi-center sample collection study in patients presenting with pigmented lesion(s) suspicious for melanoma. All suspicious lesions should meet at least one of the "ABCDE" criteria.

Key facts

Study ID

NCT04550000

Run by

DermTech

People needed

652

Starts

2019-03-01

Expected to finish

2022-07-15

Last updated by the study team

2022-10-28

Who can join

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

You may qualify if…

• Males and females at least 21 years of age
• Have a pigmented lesion suspicious for melanoma the pigmented lesion meets at least one of the "ABCDE" criteria
• The pigmented lesion mst be at least 3mm and not more than 16mm in diameter
• Patient is willing to follow the start of care to test and treat the pigmented lesion as determined by the treating physician
• Willing to have DermTech adhesive patch biopsies performed
• Must be able to complete study procedures as required by the protocol
• Willing to provide informed consent to participate in this trial

You may not qualify if…

• Require a surgical biopsy or excision of the lesion of interest prior to the DermTech non-invasive patch biopsy(ies)
• Has an ulcerated or bleeding lesion that could confound the biopsy results
• Has a suspicious lesion(s) in an area that was previously surgically biopsied
• Has a lesion that is classified as "clinically" evident melanoma appropriate for excision
• The lesion to be sampled is on the mucosal surface, palmoplantar surface or other area where adhesive patch biopsies cannot be performed
• Has a known sensitivity to adhesive patches
• Any significant medical condition that would indicate an unreasonable risk to the patient or potential interference with the study
• Lesion is in a location were sufficient removal of non-vellus hair cannot be achieved (e.g., scalp)
• Suspected non-melanoma skin cancer
• Patients with contraindication(s) to surgical biopsy -

Where it is running

• Dermatologic Surgery Center — Chevy Chase, Maryland, United States
• University of Utah Huntsman Cancer Institute — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.