Pyoderma GangrenosumNCT04792957
JAK-STAT Signaling Pathway in Pyoderma Gangrenosum
An observational study of Pyoderma Gangrenosum and Hidradenitis Suppurativa, run by Dokuz Eylul University.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pyoderma Gangrenosum, Hidradenitis Suppurativa, Psoriasis
- What is being tested?
- immunohistochemical methods
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2022to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients from İzmir Katip Çelebi University, Ataturk Education and Research Hospital Department of Rheumatology
Who may be able to join
- Pyoderma gangrenosum diagnosed with skin biopsy
- Psoriasis diagnosed with skin biopsy
- Hidradenitis suppurativa diagnosed with skin biopsy
- Skin biopsy in healthy subjects
Who cannot join
- This is a case-based study and there is no exclusion criteria
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Expression of the JAK-STAT Signaling Pathway in Pyoderma Gangrenosum Pathological Biopsy
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.
- Conditions
- Pyoderma Gangrenosum, Hidradenitis Suppurativa, Psoriasis
- Being tested
- immunohistochemical methods
- Keywords
- JAK-STAT pathway, Pyoderma Gangrenosum, Skin Biopsy
- Medical subject headings
- Pyoderma Gangrenosum, Hidradenitis Suppurativa, Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immunohistochemical methodsDiagnostic test
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 group | Role | What they receive |
|---|---|---|
| Pyoderma Gangrenosum | Skin biopsies obtained from patients with pyoderma gangrenosum will be studied to evaluate JAK/STAT pathway by using immunohistochemical methods. Receives: 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 Receives: Diagnostic Test: immunohistochemical methods | |
| Psoriasis | Skin biopsies obtained from patients with psoriasis, will be studied to evaluate JAK/STAT pathway by using immunohistochemical methods Receives: Diagnostic Test: immunohistochemical methods | |
| Healthy Subjects | Skin biopsies obtained from patients with healthy subjects, will be used to control group. Receives: Diagnostic Test: immunohistochemical methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2021
- Study start1 May 2022 (estimated)
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pyoderma GangrenosumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Sari, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792957
- Sponsor's protocol ID
- DokuzEU-Rheumatology-1
- Status last verified
- Mar 2022
- First submitted
- 8 Mar 2021
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of the JAK-STAT Signaling Pathway in Pyoderma Gangrenosum Pathological Biopsy
- ClinicalTrials.gov ID
- NCT04792957
- Acronym / sponsor ID
- DokuzEU-Rheumatology-1
- Conditions
- Pyoderma Gangrenosum, Hidradenitis Suppurativa, Psoriasis
- Keywords
- JAK-STAT pathway, Pyoderma Gangrenosum, Skin Biopsy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 11 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pyoderma Gangrenosum | – | Diagnostic Test: immunohistochemical methodsSkin biopsies obtained from patients with pyoderma gangrenosum will be studied to evaluate JAK/STAT pathway by using immunohistochemical methods. |
| Hidradenitis Suppurativa | – | Diagnostic Test: immunohistochemical methodsSkin biopsies obtained from patients with hidradenitis suppurativa, will be studied to evaluate JAK/STAT pathway by using immunohistochemical methods |
| Psoriasis | – | Diagnostic Test: immunohistochemical methodsSkin biopsies obtained from patients with psoriasis, will be studied to evaluate JAK/STAT pathway by using immunohistochemical methods |
| Healthy Subjects | – | Diagnostic Test: immunohistochemical methodsSkin biopsies obtained from patients with healthy subjects, will be used to control group. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from İzmir Katip Çelebi University, Ataturk Education and Research Hospital Department of Rheumatology
Key inclusion criteria (4 listed)
- Pyoderma gangrenosum diagnosed with skin biopsy
- Psoriasis diagnosed with skin biopsy
- Hidradenitis suppurativa diagnosed with skin biopsy
- Skin biopsy in healthy subjects
Key exclusion criteria (1 listed)
- This is a case-based study and there is no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immunohistochemical methodsThe 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. | Diagnostic test | Healthy Subjects, Hidradenitis Suppurativa, Psoriasis, Pyoderma Gangrenosum |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Pyoderma Gangrenosum and Hidradenitis Suppurativa, run by Dokuz Eylul University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ismail Sari, M.Sc (+902324122222, ismailsari35@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of JAK-STAT pathway (time frame: 15 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.