Proteomic Analysis of Sweat in Cutaneous Conditions

Study Overview
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Brief Summary
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This study will investigate a new diagnostic technology in order to expand current understanding of inflammatory and neoplastic cutaneous disease processes such as eczema, psoriasis, granuloma annulare, cutaneous lymphoma, squamous cell carcinoma, basal cell carcinoma and melanoma. Protein fragments found in sweat will be collected using a diagnostic skin patch and analyzed with mass spectrometry. The goal of this study is to identify specific protein fragment biomarkers that may further current understanding of cutaneous diseases. The protein expression patterns derived from sweat will be compared to conventional histopathologic, immunohistochemical, flow cytometry, in-situ hybridization, polymerase chain reaction, and mass spectrometry analyses of cutaneous biopsy specimens. The insight gained from this research will be used to promote advances in disease prevention and early diagnosis, identify prognostic indicators and new therapeutic targets.

Detailed Description
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The investigators propose a novel technology to be used at the bedside or in the field: an FDA approved diagnostic skin patch which harvests, concentrates, and stabilizes a panel of protein fragments derived from skin transudate or sweat. While drug delivery patches are routinely used, the technology proposed here has exactly the opposite function: the harvesting of diagnostic markers using novel affinity bait nanoparticles, bound within an adhesive skin patch. The proposed technology may overcome all major physiological barriers that have prevented the use of this biologic fluid for diagnostic testing. Sweat disease protein fragments are subject to rapid degradation due to proteases present in sweat and normal skin bacterial flora, and exist in extremely low abundance, far below the detection sensitivity of standard analysis platforms. Harvesting hydrogel nanoparticles are engineered with chemical high affinity baits so that they sequester the low abundance target analytes, and protect them from degradation indefinitely. Once applied to the skin, the nanoparticles in the patch harvest minute by minute, and protect from degradation, all candidate analytes in the sweat underneath the patch. The core shell bait nanoparticles are a completely novel technology that can amplify the sensitivity of protein fragment detection by 100 fold. No other technology exists that has a similar yield, concentration ability, and stabilization function. Once the collection is complete, the patch will be mailed to the diagnostic lab at room temperature. Upon receipt, the nanoparticle-captured analytes of interest can be eluted from the patch for routine measurement using any platform. Feasibility studies have demonstrated virtually 100 percent capture and 100 percent elution yield of low abundance interleukins in model sweat solutions. The investigators will collect sweat from healthy volunteers under Institutional Review Board approval. Mass spectrometry will be used to discover novel sweat protein fragments that have been concentrated and preserved in the patch. Low abundance labile protein fragments harvested from the nanoparticles will be measured by clinical immunoassays to verify sensitivity and precision. Data gathered from this study will be used to develop a foundation for sweat protein fragment testing of cutaneous disease.

Official Title
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Proteomic Analysis of Sweat in Cutaneous Inflammatory and Neoplastic Conditions

Conditions
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Application Site Perspiration

Intervention / Treatment
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* Device: Skin Patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who present with an inflammatory or neoplastic skin condition at approved study locations will be screened for eligibility. All patients > 18 years of age with a suspected cutaneous malignancy. Face and body sites will be included. No maximum number of areas are set and will depend on the areas deemed clinical appropriate and necessary for accurate diagnosis Exclusion Criteria: Exclusion criteria include patients enrolled in investigational drug clinical trials, patients who received or currently receive systemic chemotherapy, pregnancy, persons < 18 years of age, and persons whom are unable to consent to medical procedures themselves.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Skin Patch<br>Sweat will be collected from inflammatory and neoplastic skin lesions with an FDA approved diagnostic skin patch for analysis with mass spectrometry | Device: Skin Patch<br>* Sweat will be collected by applying a diagnostic skin patch to inflammatory and neoplastic cutaneous lesions for proteomic analysis with mass spectrometry.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of perspired protein fragments in cutaneous diseases | Mass spectrometry will be used to identify protein fragments from sweat collected from a skin patch that will be applied directly to skin lesions of eczema, psoriasis, granuloma annulare, cutaneous lymphoma, basal cell carcinoma, squamous cell carcinoma and melanoma. These protein fragments will be compared to protein fragments perspired from normal skin in order to look for signature patterns of expression that correlate to each disease entity. Low abundance labile sweat protein fragments harvested from the nanoparticles will be measured by clinical immunoassays to verify sensitivity and precision. | 1 year |