NCT04550000

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 652 (actual)
• Sponsor: DermTech · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: —

Summary

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.

Detailed description

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" (asymmetry, border, color, diameter, evolving) criteria. Patients will be consented for the study and screened against the inclusion and exclusion criteria. Once the patient is determined to be acceptable for the study they will be assigned a unique patient number and tissue collection will begin. Tissue from the lesion will be collected using DermTech's non-invasive adhesive patch kit according to the instructions for use followed by surgical biopsy. Digital dermoscopy of the lesion is preferred but not required.

Conditions

• Melanoma (Skin)
• Pigmented Skin
• Nevus

Timeline

• Start date: 2019-03-01
• Primary completion: 2022-07-15
• Completion: 2022-07-15
• First posted: 2020-09-16
• Last updated: 2022-10-28

Locations

2 sites across 1 country: United States