NCT04792957

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

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2022

Shorter than P25 for all trials

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

3 months

First QC Date

March 8, 2021

Last Update Submit

March 21, 2022

Conditions

Keywords

JAK-STAT pathwayPyoderma GangrenosumSkin Biopsy

Outcome Measures

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.

    15 years

Study Arms (4)

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

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 SubjectsHidradenitis SuppurativaPsoriasisPyoderma Gangrenosum

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients from İzmir Katip Çelebi University, Ataturk Education and Research Hospital Department of Rheumatology

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Skin biopsy

MeSH Terms

Conditions

Pyoderma GangrenosumHidradenitis SuppurativaPsoriasis

Condition Hierarchy (Ancestors)

PyodermaSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, VascularSkin UlcerSkin Diseases, BacterialBacterial InfectionsBacterial Infections and MycosesInfectionsSkin Diseases, InfectiousSuppurationHidradenitisSweat Gland DiseasesSkin Diseases, Papulosquamous

Central Study Contacts

Ismail Sari, M.Sc

CONTACT

Tuba Demirci Yıldırım, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Doctor

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 11, 2021

Study Start

May 1, 2022

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

March 23, 2022

Record last verified: 2022-03