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

Sponsor
DermTech (Other)
Overall Status
Recruiting
CT.gov ID
NCT04550000
Collaborator
(none)
1,000
2
43
500
11.6

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    1000 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    A Multi-center Sample Collection Study in Patients With Suspected Melanoma Utilizing DermTech's Non-invasive Adhesive Patch Biopsy Kits
    Actual Study Start Date :
    Mar 1, 2019
    Anticipated Primary Completion Date :
    Sep 15, 2022
    Anticipated Study Completion Date :
    Sep 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Up to 1000 samples will be compared for gene expression analysis results compared to biopsy findings. [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]

      gene expression associated with melanoma vs non-melanoma compared to surgical biopsy

    2. Up to 1000 samples will be compared to biopsy results for DNA mutations [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]

      Dna mutations associated with more aggressive forms of melanoma

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    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 -

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dermatologic Surgery Center Chevy Chase Maryland United States 20185
    2 University of Utah Huntsman Cancer Institute Salt Lake City Utah United States 84112

    Sponsors and Collaborators

    • DermTech

    Investigators

    • Study Director: James Rock, DermTech

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    DermTech
    ClinicalTrials.gov Identifier:
    NCT04550000
    Other Study ID Numbers:
    • 19-01
    First Posted:
    Sep 16, 2020
    Last Update Posted:
    Sep 20, 2021
    Last Verified:
    Sep 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by DermTech
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 20, 2021