NCT02768090

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 25, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 11, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2017

Completed
Last Updated

October 16, 2023

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

May 9, 2016

Last Update Submit

October 12, 2023

Conditions

Application Site Perspiration

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Skin Patch

EXPERIMENTAL

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

Interventions

Skin PatchDEVICE

Sweat will be collected by applying a diagnostic skin patch to inflammatory and neoplastic cutaneous lesions for proteomic analysis with mass spectrometry.

Skin Patch

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hollywood Dermatology

Hollywood, Florida, 33021, United States

Location

Related Publications (2)

  • Fredolini C, Meani F, Reeder KA, Rucker S, Patanarut A, Botterell PJ, Bishop B, Longo C, Espina V, Petricoin EF 3rd, Liotta LA, Luchini A. Concentration and Preservation of Very Low Abundance Biomarkers in Urine, such as Human Growth Hormone (hGH), by Cibacron Blue F3G-A Loaded Hydrogel Particles. Nano Res. 2008 Dec;1(6):502-518. doi: 10.1007/s12274-008-8054-z.

    PMID: 20467576BACKGROUND

  • Longo C, Patanarut A, George T, Bishop B, Zhou W, Fredolini C, Ross MM, Espina V, Pellacani G, Petricoin EF 3rd, Liotta LA, Luchini A. Core-shell hydrogel particles harvest, concentrate and preserve labile low abundance biomarkers. PLoS One. 2009;4(3):e4763. doi: 10.1371/journal.pone.0004763. Epub 2009 Mar 10.

    PMID: 19274087BACKGROUND

MeSH Terms

Interventions

Transdermal Patch

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Laszlo Karai, MD, PhD

    Larkin Community Hospital

    PRINCIPAL INVESTIGATOR

  • Edwardo Weiss, MD

    Larkin Community Hospital

    STUDY DIRECTOR

  • Bertha Baum, DO

    Larkin Community Hospital

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2016

First Posted

May 11, 2016

Study Start

February 25, 2016

Primary Completion

January 30, 2017

Study Completion

January 30, 2017

Last Updated

October 16, 2023

Record last verified: 2023-10

Locations

US(1)