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

NCT04563949 | Completed FDA Drug

• 1 other identifier: 17-02
• Study Type: observational
• Target: 323
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Melanoma Detection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Results of PLA results compared to biopsy

  approximately up to 24 months

Study Arms (2)

PLA-

PLA- initially and repeat testing 1-2 years later

Other: Repeat Testing

PLA+

Not eligible for the study

Interventions

Repeat Testing OTHER

Repeat Testing with the PLA will be conducted

PLA-

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

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. -

Sponsors & Collaborators

• DermTech: lead

Study Sites (1)

West Dermatology

San Diego, California, 92121, United States

Location

Related Publications (2)

• 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.

  PMID: 28445578 BACKGROUND

• 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.

  PMID: 27707590 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

RNA extracted from DermTech's PLA assay for gene expression observed in melanoma

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 25, 2020
• Study Start: November 16, 2017
• Primary Completion: November 12, 2020
• Study Completion: December 15, 2020
• Last Updated: March 26, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)