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

Melanoma (Skin) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04550000
• Other study ID #: 19-01
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: July 15, 2022

Study information

• Verified date: March 2021
• Source: DermTech
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 652
• Est. completion date: July 15, 2022
• Est. primary completion date: July 15, 2022
• Gender: All
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

1. Males and females at least 21 years of age

2. Have a pigmented lesion suspicious for melanoma the pigmented lesion meets at least one of the "ABCDE" criteria

3. The pigmented lesion mst be at least 3mm and not more than 16mm in diameter

4. Patient is willing to follow the start of care to test and treat the pigmented lesion as determined by the treating physician

5. Willing to have DermTech adhesive patch biopsies performed

6. Must be able to complete study procedures as required by the protocol

7. Willing to provide informed consent to participate in this trial

Exclusion Criteria:

1. Require a surgical biopsy or excision of the lesion of interest prior to the DermTech non-invasive patch biopsy(ies)

2. Has an ulcerated or bleeding lesion that could confound the biopsy results

3. Has a suspicious lesion(s) in an area that was previously surgically biopsied

4. Has a lesion that is classified as "clinically" evident melanoma appropriate for excision

5. The lesion to be sampled is on the mucosal surface, palmoplantar surface or other area where adhesive patch biopsies cannot be performed

6. Has a known sensitivity to adhesive patches

7. Any significant medical condition that would indicate an unreasonable risk to the patient or potential interference with the study

8. Lesion is in a location were sufficient removal of non-vellus hair cannot be achieved (e.g., scalp)

9. Suspected non-melanoma skin cancer

10. Patients with contraindication(s) to surgical biopsy -

Related Conditions & MeSH terms

• Melanoma
• Melanoma (Skin)
• Nevus
• Pigmentation Disorders
• Pigmented Skin

Locations

Country	Name	City	State
United States	Dermatologic Surgery Center	Chevy Chase	Maryland
United States	University of Utah Huntsman Cancer Institute	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
DermTech

Country where clinical trial is conducted

United States, 

References & Publications (2)

Gerami P, Yao Z, Polsky D, Jansen B, Busam K, Ho J, Martini M, Ferris LK. Development and validation of a noninvasive 2-gene molecular assay for cutaneous melanoma. J Am Acad Dermatol. 2017 Jan;76(1):114-120.e2. doi: 10.1016/j.jaad.2016.07.038. Epub 2016 — View Citation

Yao Z, Allen T, Oakley M, Samons C, Garrison D, Jansen B. Analytical Characteristics of a Noninvasive Gene Expression Assay for Pigmented Skin Lesions. Assay Drug Dev Technol. 2016 Aug;14(6):355-63. doi: 10.1089/adt.2016.724. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Up to 1000 samples will be compared for gene expression analysis results compared to biopsy findings.	gene expression associated with melanoma vs non-melanoma compared to surgical biopsy	Samples will be extracted and analyzed once up to 1000 samples have been collected and compared to surgical biopsy reports. Analysis results are expected in 2021
Primary	Up to 1000 samples will be compared to biopsy results for DNA mutations	Dna mutations associated with more aggressive forms of melanoma	Samples will be extracted and analyzed once up to 1000 samples have been collected and compared to surgical reports and DNA mutation analysis. Analysis results are expected in 2021