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

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ClinicalTrials.gov Identifier: NCT04563949
Recruitment Status : Recruiting
First Posted : September 25, 2020
Last Update Posted : September 25, 2020
Sponsor:
Information provided by (Responsible Party):
DermTech

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.

Condition or disease Intervention/treatment
Melanoma Detection Diagnostic Test: DermTech PLA Assay

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : November 16, 2017
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : October 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Biopsy Melanoma


Intervention Details:
  • Diagnostic Test: DermTech PLA Assay
    PLA assay measuring PRAME and LINC for gene expression
    Other Name: Pigmented Lesion Assay (PLA)


Primary Outcome Measures :
  1. Proportion of subjects without surgical biopsy [ Time Frame: approximately up to 24 months ]
    The proportion of subjects who exit the study without surgical biopsy out to approximately up to 24 months ± SOC


Secondary Outcome Measures :
  1. Results of PLA results compared to biopsy [ Time Frame: approximately up to 24 months ]
    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.


Biospecimen Retention:   Samples Without DNA
RNA extracted from DermTech's PLA assay for gene expression observed in melanoma


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04563949


Locations
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United States, California
West Dermatology Recruiting
San Diego, California, United States, 92121
Contact: Brook Brouha, MD    858-657-1004    bbrouha@gmail.com   
Contact: Jenna Hannon    858 657 1004 ext 128    jhannon@CLDerm.com   
Sponsors and Collaborators
DermTech
Publications:
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Responsible Party: DermTech
ClinicalTrials.gov Identifier: NCT04563949    
Other Study ID Numbers: 17-02
First Posted: September 25, 2020    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: All samples received have been de-identified with a study and subject specific number.

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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
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas