- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04792957
JAK-STAT Signaling Pathway in Pyoderma Gangrenosum
Expression of the JAK-STAT Signaling Pathway in Pyoderma Gangrenosum Pathological Biopsy
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Ismail Sari, M.Sc
- Phone Number: +902324122222
- Email: ismailsari35@gmail.com
Study Contact Backup
- Name: Tuba Demirci Yıldırım, M.D.
- Phone Number: +902324122222
- Email: tubademirci87@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
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
|
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
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
15 years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Sweat Gland Diseases
- Skin Diseases
- Infections
- Skin Ulcer
- Bacterial Infections
- Bacterial Infections and Mycoses
- Skin Diseases, Vascular
- Skin Diseases, Infectious
- Skin Diseases, Papulosquamous
- Suppuration
- Skin Diseases, Bacterial
- Psoriasis
- Hidradenitis Suppurativa
- Hidradenitis
- Pyoderma
- Pyoderma Gangrenosum
Other Study ID Numbers
- DokuzEU-Rheumatology-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psoriasis
-
ProgenaBiomeRecruitingPsoriasis | Psoriasis Vulgaris | Psoriasis of Scalp | Psoriatic Plaque | Psoriasis Universalis | Psoriasis Face | Psoriasis Nail | Psoriasis Diffusa | Psoriasis Punctata | Psoriasis Palmaris | Psoriasis Circinata | Psoriasis Annularis | Psoriasis Genital | Psoriasis GeographicaUnited States
-
Clin4allRecruitingPsoriasis of Scalp | Psoriasis Nail | Psoriasis Palmaris | Psoriasis Genital | Psoriasis PlantarisFrance
-
Innovaderm Research Inc.CompletedScalp Psoriasis | Pustular Palmo-plantar Psoriasis | Non-pustular Palmo-plantar Psoriasis | Elbow Psoriasis | Lower Leg PsoriasisCanada
-
AmgenCompletedPsoriasis-Type Psoriasis | Plaque-Type PsoriasisUnited States
-
Centre of Evidence of the French Society of DermatologyRecruitingPsoriasis | Psoriasis Vulgaris | Psoriasis of Scalp | Psoriatic Plaque | Psoriasis Universalis | Psoriasis Palmaris | Psoriatic Erythroderma | Psoriatic Nail | Psoriasis Guttate | Psoriasis Inverse | Psoriasis PustularFrance
-
UCB Biopharma S.P.R.L.CompletedModerate to Severe Psoriasis | Generalized Pustular Psoriasis and Erythrodermic PsoriasisJapan
-
TakedaRecruitingGeneralized Pustular Psoriasis | Erythrodermic PsoriasisJapan
-
Janssen Pharmaceutical K.K.RecruitingGeneralized Pustular Psoriasis | Erythrodermic PsoriasisJapan
-
Eli Lilly and CompanyCompletedGeneralized Pustular Psoriasis | Erythrodermic PsoriasisJapan
-
Shanghai Huaota Biopharmaceutical Co., Ltd.RecruitingGeneralized Pustular Psoriasis (GPP)China
Clinical Trials on immunohistochemical methods
-
Port Said University hospitalMansoura University HospitalCompleted
-
Kanuni Sultan Suleyman Training and Research HospitalUnknown
-
Centre Hospitalier Universitaire de Saint EtienneCompleted
-
WellSpan HealthActive, not recruitingEndometrial Hyperplasia | Lynch Syndrome | Endometrial Cancer | Microsatellite Instability | Mismatch Repair DeficiencyUnited States
-
National Taiwan University HospitalWithdrawn
-
Fondazione Policlinico Universitario Agostino Gemelli...Active, not recruitingCancer | Squamous Cell Carcinoma of the Head and NeckItaly
-
Samsung Medical CenterCompletedMalignant Lymphoma | P13K-AKT Pathway DeregulationKorea, Republic of
-
National Taiwan University HospitalUnknown
-
Fundació Institut de Recerca de l'Hospital de la...RecruitingThumb OsteoarthritisSpain
-
Lei LiUnknownCervical Intraepithelial Neoplasia | Cervical Cancer Screening | Histology | p16 Protein | Cytology | High-risk Human Papillomavirus | Diagnostic AccuracyChina