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 : July 26, 2022
|Condition or disease||Intervention/treatment|
|Dermatologic Diseases||Other: non-invasive sample collection of skin tissue|
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.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|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|
- Other: non-invasive sample collection of skin tissue
Both lesional and non-lesional skin will be sampled with up to 24 adhesive patches.
- 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
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
|Contact: James Rockfirstname.lastname@example.org|
|Contact: Susan Huynhemail@example.com|
|United States, Colorado|
|Elizabeth S. Robinson, MD||Recruiting|
|Denver, Colorado, United States, 80237|
|Contact: Elizabeth S Robinson, MD 303-850-9715 firstname.lastname@example.org|
|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|
|Study Director:||James Rock, MS||DermTech|