ClinicalTrials.gg
Status unknownNCT04792957Updated Mar 23, 2022

JAK-STAT Signaling Pathway in Pyoderma Gangrenosum

An observational study in Pyoderma Gangrenosum, Hidradenitis Suppurativa and Psoriasis, sponsored by Dokuz Eylul University. Status unknown. Open to participants aged 18 Years to 90 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-23.

Sponsored by Dokuz Eylul University · Observational

The sponsor has not verified this record recently (last verified Mar 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
120
Ages
18 Years to 90 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Pyoderma Gangrenosum
  • Hidradenitis Suppurativa
  • Psoriasis

Keywords

  • JAK-STAT pathway
  • Pyoderma Gangrenosum
  • Skin Biopsy
03

In context

Pyoderma Gangrenosum

36 studies on the registry are indexed under Pyoderma Gangrenosum; 7 are open to participants now.

Browse Pyoderma Gangrenosum studies →

Lead sponsor

Dokuz Eylul University is the lead sponsor of 261 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • This is a case-based study and there is no exclusion criteria
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
120 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • 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

  • 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

  • Psoriasis

    Skin biopsies obtained from patients with psoriasis, will be studied to evaluate JAK/STAT pathway by using immunohistochemical methods

    Diagnostic Test: immunohistochemical methods

  • Healthy Subjects

    Skin biopsies obtained from patients with healthy subjects, will be used to control group.

    Diagnostic Test: immunohistochemical methods

Interventions

  • Diagnostic testimmunohistochemical 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.

06

What researchers measure

Primary outcomes

  1. Expression of JAK-STAT pathway

    Expression of JAK1, JAK2, JAK3, Tyrosine Kinase 2, STAT1, STAT2, STAT3, STAT3, STAT4, STAT5 and STAT6 in tissue levels in PG.

    Time frame: 15 years

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04792957
Responsible party
Ismail Sari (Professor Doctor, Dokuz Eylul University) — Principal investigator
First posted
Mar 11, 2021
Start date
May 1, 2022 (estimated)
Primary completion
Jul 31, 2022 (estimated)
Completion
Jul 31, 2022 (estimated)
Last update
Mar 23, 2022

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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