A Sample Collection Study Utilizing DermTech's Non-invasive Adhesive Patch Biopsy Kits

  • STATUS
    Recruiting
  • End date
    Dec 15, 2023
  • participants needed
    1000
  • sponsor
    DermTech
Updated on 4 October 2022

Summary

This sample collection study will recruit subjects with a variety of skin conditions from up to 15 geographically dispersed sites in the United States. Skin samples will be collected with the DermTech Adhesive Patch Kit from both lesional and non-lesional skin. Subjects may also be asked to return at a future data for additional collections. Collected skin samples will be analyzed for gene expression information, DNA and the microbiome.

Description

This is a multi-center, sample collection study to obtain skin tissue for gene expression, DNA mutation, microbiome and related analyses from subjects with dermatologic conditions. After subjects are consented for the study, site staff will collect skin tissue from the subject using DermTech's non-invasive skin collection kit. Skin samples will be collected from both lesional and non-lesional skin as applicable.

Additional skin tissue may be collected from the lesion and non-lesional area with the DermTech non-invasive skin collection kit at a later time point as directed by DermTech to track the dermatologic condition for progression, improvements or lack of response to standard of care therapy.

Each Dermtech non-invasive skin collection kit will consist of the sequential application of up to 24 individual patches to lesional and non-lesional areas. Sites should apply the DermTech patches to the most severe lesion(s).

Dermatologic conditions include but are not limited too; atopic dermatitis, atopic asthma, skin cancers (i.e., basal, and squamous carcinoma, melanoma, etc.), lupus, rheumatoid and psoriatic arthritis, gutate and plaque psoriasis, palmoplantar psoriasis, palmoplantar contact dermatitis, fungal infections and cutaneous T cell Lymphoma. Skin tissue will be collected using DermTech's proprietary adhesive patch skin biopsy kit and extracted for analysis at DermTech's CLIA and CAP Laboratory. Analysis of the samples will include gene expression signatures and DNA mutation as well as microbiome analyses associated with the medical conditions of interest.

Details
Condition Dermatosis, Congenital Skin Diseases, Skin Conditions, Skin Condition, Congenital Skin Diseases, Skin Conditions, skin disorder, skin disease, skin disorders, dermatological disease, disease skin, skin diseases, dermatological diseases, dermatoses
Treatment non-invasive sample collection of skin tissue
Clinical Study IdentifierNCT04668846
SponsorDermTech
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Males and females at least 21 years of age
Have a dermatologic condition of interesting including but not limited too; atopic dermatitis, atopic asthma, skin cancers (i.e., basal, and squamous carcinoma, melanoma, etc.), lupus, rheumatoid and psoriatic arthritis, gutate and plaque psoriasis, palmoplantar psoriasis, palmoplantar contact dermatitis, fungal infections and cutaneous T cell Lymphoma that can be non-invasively biopsied with DermTech's adhesive patch kit
Willing to allow additional DermTech adhesive patch biopsies to be performed; and
Willing to provide informed consent to participate in this trial

Exclusion Criteria

Required a surgical biopsy or excision prior to a 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
Has an allergy to tape or latex rubber; and
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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