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JAK-STAT Signaling Pathway in Pyoderma Gangrenosum

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ClinicalTrials.gov Identifier: NCT04792957
Recruitment Status : Not yet recruiting
First Posted : March 11, 2021
Last Update Posted : August 17, 2021
Sponsor:
Information provided by (Responsible Party):
Ismail Sari, Dokuz Eylul University

Study Description
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Brief Summary:
The investigators hypothese that Janus kinase/signal transduction and activator of transcription (JAK/STAT) signaling pathway play a key role in pathophysiology of pyoderma gangrenosum (PG). In this study JAK/STAT signaling pathway will be investigated in the skin biopsies of PG patients

Condition or disease Intervention/treatment
Pyoderma Gangrenosum Hidradenitis Suppurativa Psoriasis Diagnostic Test: immunohistochemical methods

Detailed Description:

Cytokines are key molecules in the pathogenesis of inflammatory diseases. These molecules exert their effects through cell surface receptors and intracellular signaling pathways. Janus kinase/signal transduction and activator of transcription (JAK/STAT) signaling pathway is implicated in the pathogenesis of several autoimmune diseases. Pyoderma gangrenosum (PG) is an inflammatory skin disease characterized by progressive and recurrent skin ulceration of destructive course. Treatment of PG requires aggressive immunosuppressive therapy but despite the use of several agents, including tumor necrosis factor inhibitory treatments there is still an unmet need in refractory PG. Recent reports suggested activation of JAK/STAT pathway in PG and some case-based studies suggested the beneficial effect of JAK-STAT inhibitory agent in the treatment of PG.

Skin biopsies obtained from PG, hidradenitis suppurativa, psoriasis and healthy subjects will be studied to evaluate JAK/STAT pathway by using immunohistochemical methods. The following immunohistochemical stains will be used to evaluate the expression of JAK/STAT pathway: JAK1, JAK2, JAK3, Tyrosine Kinase 2, STAT1, STAT2, STAT3, STAT3, STAT4, STAT5 and STAT6. Staining intensity will be recorded categorically (negative and positive). The positive staining will also be graded semi-quantitively as follows: mildly positive, moderately positive and strongly positive.

Study Design
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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Expression of the JAK-STAT Signaling Pathway in Pyoderma Gangrenosum Pathological Biopsy
Estimated Study Start Date : December 1, 2021
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Groups and Cohorts
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Group/Cohort Intervention/treatment
Pyoderma Gangrenosum
Skin biopsies obtained from patients with pyoderma gangrenosum will be studied to evaluate JAK/STAT pathway by using immunohistochemical methods.
 Diagnostic Test: immunohistochemical methods
The following immunohistochemical stains will be used to evaluate the expression of JAK/STAT pathway: JAK1, JAK2, JAK3, Tyrosine Kinase 2, STAT1, STAT2, STAT3, STAT3, STAT4, STAT5 and STAT6. Staining intensity will be recorded categorically (negative and positive). The positive staining will also be graded semi-quantitively as follows: mildly positive, moderately positive and strongly positive.
Hidradenitis Suppurativa
Skin biopsies obtained from patients with hidradenitis suppurativa, will be studied to evaluate JAK/STAT pathway by using immunohistochemical methods
 Diagnostic Test: immunohistochemical methods
The following immunohistochemical stains will be used to evaluate the expression of JAK/STAT pathway: JAK1, JAK2, JAK3, Tyrosine Kinase 2, STAT1, STAT2, STAT3, STAT3, STAT4, STAT5 and STAT6. Staining intensity will be recorded categorically (negative and positive). The positive staining will also be graded semi-quantitively as follows: mildly positive, moderately positive and strongly positive.
Psoriasis
Skin biopsies obtained from patients with psoriasis, will be studied to evaluate JAK/STAT pathway by using immunohistochemical methods
 Diagnostic Test: immunohistochemical methods
The following immunohistochemical stains will be used to evaluate the expression of JAK/STAT pathway: JAK1, JAK2, JAK3, Tyrosine Kinase 2, STAT1, STAT2, STAT3, STAT3, STAT4, STAT5 and STAT6. Staining intensity will be recorded categorically (negative and positive). The positive staining will also be graded semi-quantitively as follows: mildly positive, moderately positive and strongly positive.
Healthy Subjects
Skin biopsies obtained from patients with healthy subjects, will be used to control group.
 Diagnostic Test: immunohistochemical methods
The following immunohistochemical stains will be used to evaluate the expression of JAK/STAT pathway: JAK1, JAK2, JAK3, Tyrosine Kinase 2, STAT1, STAT2, STAT3, STAT3, STAT4, STAT5 and STAT6. Staining intensity will be recorded categorically (negative and positive). The positive staining will also be graded semi-quantitively as follows: mildly positive, moderately positive and strongly positive.


Outcome Measures
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Primary Outcome Measures :
  1. Expression of JAK-STAT pathway [ Time Frame: 15 years ]
    Expression of JAK1, JAK2, JAK3, Tyrosine Kinase 2, STAT1, STAT2, STAT3, STAT3, STAT4, STAT5 and STAT6 in tissue levels in PG.


Biospecimen Retention:   Samples Without DNA
Skin biopsy

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients from İzmir Katip Çelebi University, Ataturk Education and Research Hospital Department of Rheumatology
Criteria

Inclusion Criteria:

  • Pyoderma gangrenosum diagnosed with skin biopsy
  • Psoriasis diagnosed with skin biopsy
  • Hidradenitis suppurativa diagnosed with skin biopsy
  • Skin biopsy in healthy subjects

Exclusion Criteria:

- This is a case-based study and there is no exclusion criteria

Contacts and Locations
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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): NCT04792957


Contacts
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Contact: Ismail Sari, M.Sc +902324122222 ismailsari35@gmail.com
Contact: Tuba Demirci Yıldırım, M.D. +902324122222 tubademirci87@gmail.com

Sponsors and Collaborators
Dokuz Eylul University
More Information
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Responsible Party: Ismail Sari, Professor Doctor, Dokuz Eylul University
ClinicalTrials.gov Identifier: NCT04792957    
Other Study ID Numbers: DokuzEU-Rheumatology-1
First Posted: March 11, 2021    Key Record Dates
Last Update Posted: August 17, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ismail Sari, Dokuz Eylul University:
JAK-STAT pathway
Pyoderma Gangrenosum
Skin Biopsy
Additional relevant MeSH terms:
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Hidradenitis Suppurativa
Psoriasis
Hidradenitis
Pyoderma
Pyoderma Gangrenosum
Skin Diseases, Papulosquamous
Skin Diseases
Sweat Gland Diseases
 Skin Diseases, Bacterial
Bacterial Infections
Bacterial Infections and Mycoses
Infections
Skin Diseases, Infectious
Suppuration
Skin Diseases, Vascular
Skin Ulcer