ClinicalTrials.gov
ClinicalTrials.gov Menu

Proteomic Analysis of Sweat in Cutaneous Conditions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02768090
Recruitment Status : Recruiting
First Posted : May 11, 2016
Last Update Posted : August 25, 2016
Sponsor:
Collaborator:
George Mason University
Information provided by (Responsible Party):
Laszlo J Karai, Larkin Community Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Application Site Perspiration Device: Skin Patch Not Applicable

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Proteomic Analysis of Sweat in Cutaneous Inflammatory and Neoplastic Conditions
Study Start Date : August 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sweat

Arm Intervention/treatment
Experimental: Skin Patch
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
Sweat will be collected by applying a diagnostic skin patch to inflammatory and neoplastic cutaneous lesions for proteomic analysis with mass spectrometry.




Primary Outcome Measures :
  1. Analysis of perspired protein fragments in cutaneous diseases [ Time Frame: 1 year ]
    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.



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.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT02768090


Contacts
Contact: Laszlo Karai, MD, PhD 888-499-3376 lkarai@auroradx.com
Contact: Bertha Baum, DO (954) 961-1200 drberthbaum@yahoo.com

Locations
United States, Florida
Hollywood Dermatology Recruiting
Hollywood, Florida, United States, 33021
Contact: Bertha Baum, DO    954-961-1200    drberthbaum@yahoo.com   
Contact: Rebecca Suarez    (954) 961-1200    rsuarez@hollywooddermatology.com   
Sponsors and Collaborators
Laszlo J Karai
George Mason University
Investigators
Principal Investigator: Laszlo Karai, MD, PhD Larkin Community Hospital
Study Director: Edwardo Weiss, MD Larkin Community Hospital
Study Chair: Bertha Baum, DO Larkin Community Hospital