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

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

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.

Study Overview

• Status: Completed
• Conditions: Melanoma Detection
• Intervention / Treatment: Other: Repeat Testing

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 323

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • West Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Males and females the treating physician chose to use the PLA on;
2. 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;
3. Willing to permit subsequent PLA assays to be performed on suspicious lesions;
4. Willing to follow standard of care treatment for the lesion(s) as determined by the treating physician;
5. 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
6. Willing to provide informed consent to participate in this trial.

Exclusion Criteria:

1. Has confirmed melanoma or a suspicious lesion that required a surgical biopsy or excision prior to the intial PLA on that lesion of interest;
2. Has an ulcerated or bleeding lesion that could cofound the PLA results;
3. Has a suspicious lesion(s) in an area that was previously surgically biopsied;
4. The lesion(s) is on the palms, mucosal surface, or other area where adhesive patch biopsies cannot be performed;
5. Has an allergy to tape or latex rubber;
6. 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
7. 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. -

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PLA-; PLA- initially and repeat testing 1-2 years later	Other: Repeat Testing; Repeat Testing with the PLA will be conducted
PLA+; Not eligible for the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	approximately up to 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	approximately up to 24 months

Collaborators and Investigators

• Sponsor: DermTech

Publications and helpful links

General Publications

• Ferris LK, Jansen B, Ho J, Busam KJ, Gross K, Hansen DD, Alsobrook JP 2nd, Yao Z, Peck GL, Gerami P. Utility of a Noninvasive 2-Gene Molecular Assay for Cutaneous Melanoma and Effect on the Decision to Biopsy. JAMA Dermatol. 2017 Jul 1;153(7):675-680. doi: 10.1001/jamadermatol.2017.0473.
• 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 Oct 1.

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2017
• Primary Completion (Actual): November 12, 2020
• Study Completion (Actual): December 15, 2020

Study Registration Dates

• First Submitted: September 21, 2020
• First Submitted That Met QC Criteria: September 21, 2020
• First Posted (Actual): September 25, 2020

Study Record Updates

• Last Update Posted (Actual): March 26, 2021
• Last Update Submitted That Met QC Criteria: March 24, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Nevi and Melanomas; Melanoma
• Other Study ID Numbers: 17-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: All samples received have been de-identified with a study and subject specific number.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No