Proteomic Analysis of Sweat in Cutaneous Conditions

October 12, 2023 updated by: Larkin Community Hospital

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Hollywood, Florida, United States, 33021
        • Hollywood Dermatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Larkin Community Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
George Mason University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 30, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 9, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 11, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 12, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LCH-1-012016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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