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The Ohio State University Dermatology Biorepository

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ClinicalTrials.gov Identifier: NCT03146676
Recruitment Status : Recruiting
First Posted : May 10, 2017
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
Ben H Kaffenberger, Ohio State University

Brief Summary:
Analysis of Gene expression and microbiome profiling in hidradenitis suppurativa to identify immunological biomarkers of disease activity.

Condition or disease
Hidradenitis Suppurativa

Detailed Description:

A variety of molecular techniques can be used to investigate diseases by analyzing protein, DNA, and RNA. Flow cytometry, Polymerase chain reaction (PCR), histology and immunohistochemistry are assays which can identify specific cell populations and provide valuable information regarding the pathologic characteristics of those populations. Flow cytometry analyzes the surface markers of cells. Histology and immunohistochemistry further characterize surface and cellular molecules and aid in the diagnosis of certain skin diseases. Gene expression profiling allows investigators to examine the genes detectable to determine the function of the cells involved, and PCR techniques are useful for the diagnosis of certain conditions and for DNA analysis.

By procuring blood, skin tissue, and swab samples from patients with and without neoplastic and inflammatory skin disorders at the time of their appointments, the hypothesize that future translational research can be conducted on such specimens using the aforementioned techniques to further understand disease mechanisms in cutaneous disorders, and to potentially discover defective function and genetic mutations within cells from patients with neoplastic and inflammatory skin disorders. By establishing a tissue bank, we aim to lay the foundation for future work that will improve our understanding of the biology and natural history of neoplastic and inflammatory cutaneous diseases.


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Study Type : Observational
Estimated Enrollment : 175 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: The Ohio State University Dermatology Biorepository
Actual Study Start Date : April 19, 2017
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Source of clinical specimens for the future study of neoplastic and inflammatory skin disorders [ Time Frame: 1 year ]
    Analysis of Gene expression and microbiome profiling in hidradenitis suppurativa to identify immunological biomarkers of disease activity


Biospecimen Retention:   Samples With DNA
Skin Tissue, Peripheral blood mononuclear cells, skin swabs, and saliva.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Any person that meets the inclusion/exclusion criteria with one active hidradenitis suppurativa lesion.
Criteria

Inclusion Criteria:

  • Seen by an Ohio State Univeristy (OSU) Dermatology provider on the main University Hospital campus, including the James Cancer Hospital, OSU Dermatology East, OSU Dermatology at the Ohio State Eye and Ear Institute, Martha Morehouse Medical Pavilion, and OSU Dermatology at Upper Arlington after the date of approval of this protocol
  • Ability to provide informed consent, or parent or legal guardian capable of providing consent for child or mentally handicapped individuals
  • Willingness to participate in a research study.

Exclusion Criteria:

  • Inability to provide informed consent

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): NCT03146676


Contacts
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Contact: Leah Kofmehl 614-366-2025 leah.kofmehl@osumc.edu
Contact: Aleitha Gates 614-366-9201 aleitha.gates@osumc.edu

Locations
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United States, Ohio
OSU Dermatology West Recruiting
Columbus, Ohio, United States, 43215
Contact: Leah Kofmehl    614-366-2025    Leah.Kofmehl@osumc.edu   
Contact: aleitha gates    614-366-9201    aleitha.gates@osumc.edu   
Principal Investigator: Benjamin Kaffenberger, MD         
Principal Investigator: Jessica Kaffenberger, MD         
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: Benjamin Kaffenberger, MD Dermatologist
Principal Investigator: Jessica Kaffenberger, MD Dermatologist

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Responsible Party: Ben H Kaffenberger, Dermatologist, Ohio State University
ClinicalTrials.gov Identifier: NCT03146676     History of Changes
Other Study ID Numbers: 2010H0331
First Posted: May 10, 2017    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Hidradenitis
Sweat Gland Diseases
Skin Diseases
Skin Diseases, Bacterial
Bacterial Infections
Skin Diseases, Infectious
Infection
Suppuration