Proteomic Analysis of Sweat in Cutaneous Conditions
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/4/2016 |
| Start Date: | September 2016 |
| Contact: | Laszlo Karai, MD, PhD |
| Email: | lkarai@auroradx.com |
| Phone: | 888-499-3376 |
Proteomic Analysis of Sweat in Cutaneous Inflammatory and Neoplastic Conditions
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.
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.
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.
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.
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.
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