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Trial record 1 of 2 for:    A Sample Collection Study Utilizing DermTech's Non-invasive Adhesive Patch Biopsy Kits
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A Sample Collection Study Utilizing DermTech's Non-invasive Adhesive Patch Biopsy Kits

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ClinicalTrials.gov Identifier: NCT04668846
Recruitment Status : Recruiting
First Posted : December 16, 2020
Last Update Posted : December 16, 2020
Sponsor:
Information provided by (Responsible Party):
DermTech

Brief 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.

Condition or disease Intervention/treatment
Dermatologic Diseases Other: non-invasive sample collection of skin tissue

Detailed 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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Multicenter Sample Collection Study Utilizing DermTech's Non-invasive Adhesive Patch Biopsy Kits in Subjects With a Variety of Dermatologic Conditions
Actual Study Start Date : October 1, 2020
Estimated Primary Completion Date : October 30, 2023
Estimated Study Completion Date : December 15, 2023

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: non-invasive sample collection of skin tissue
    Both lesional and non-lesional skin will be sampled with up to 24 adhesive patches.


Primary Outcome Measures :
  1. Gene Expression Analysis [ Time Frame: 24 months ]
    To collect skin tissue from subjects with a variety of dermatologic conditions, both lesional and non-lesional areas to analyze for unique gene signatures


Biospecimen Retention:   Samples With DNA
Non-invasive collected skin samples will be collected and banked for future analysis.


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
Sampling Method:   Non-Probability Sample
Study Population
Subjects with a variety of dermatologic conditions will have both lesional and non-lesional skin collected using the DermTech non-invasive adhesive patch kit. 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
Criteria

Inclusion Criteria:

  1. Males and females at least 21 years of age;
  2. 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;
  3. Willing to allow additional DermTech adhesive patch biopsies to be performed; and
  4. Willing to provide informed consent to participate in this trial.

Exclusion Criteria:

  1. Required a surgical biopsy or excision prior to a 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. Has an allergy to tape or latex rubber; and
  5. 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.

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): NCT04668846


Contacts
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Contact: James Rock 18582052736 jrock@dermtech.com

Locations
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United States, Colorado
Elizabeth S. Robinson, MD Recruiting
Denver, Colorado, United States, 80237
Contact: Elizabeth S Robinson, MD    303-850-9715    robinson.liz@gmail.com   
United States, Florida
Skin Care Research, LLC Recruiting
Boca Raton, Florida, United States, 33486
Contact: Lori Aptekar, MBA    561-948-3116    Lori.Aptekar.SCR@gmail.com   
Sponsors and Collaborators
DermTech
Publications:
Krueger G, Jansen B, Yao Z. Non-Invasive Gene Expression Analysis Assay for Psoriasis. Poster Presentation American Academy of Dermatology. March 2017.

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Responsible Party: DermTech
ClinicalTrials.gov Identifier: NCT04668846    
Other Study ID Numbers: 17-06
First Posted: December 16, 2020    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Skin Diseases