Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-25 @ 4:40 PM
Study NCT ID:
NCT04792957
Status:
UNKNOWN
Last Update Posted:
2022-03-23
First Post:
2021-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
JAK-STAT Signaling Pathway in Pyoderma Gangrenosum
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017511', 'term': 'Pyoderma Gangrenosum'}, {'id': 'D017497', 'term': 'Hidradenitis Suppurativa'}, {'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D011711', 'term': 'Pyoderma'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D017192', 'term': 'Skin Diseases, Bacterial'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D013492', 'term': 'Suppuration'}, {'id': 'D016575', 'term': 'Hidradenitis'}, {'id': 'D013543', 'term': 'Sweat Gland Diseases'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Skin biopsy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-21', 'studyFirstSubmitDate': '2021-03-08', 'studyFirstSubmitQcDate': '2021-03-08', 'lastUpdatePostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Expression of JAK-STAT pathway', 'timeFrame': '15 years', 'description': 'Expression of JAK1, JAK2, JAK3, Tyrosine Kinase 2, STAT1, STAT2, STAT3, STAT3, STAT4, STAT5 and STAT6 in tissue levels in PG.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['JAK-STAT pathway', 'Pyoderma Gangrenosum', 'Skin Biopsy'], 'conditions': ['Pyoderma Gangrenosum', 'Hidradenitis Suppurativa', 'Psoriasis']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nSkin 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from İzmir Katip Çelebi University, Ataturk Education and Research Hospital Department of Rheumatology', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pyoderma gangrenosum diagnosed with skin biopsy\n* Psoriasis diagnosed with skin biopsy\n* Hidradenitis suppurativa diagnosed with skin biopsy\n* Skin biopsy in healthy subjects\n\nExclusion Criteria:\n\n\\- This is a case-based study and there is no exclusion criteria'}, 'identificationModule': {'nctId': 'NCT04792957', 'briefTitle': 'JAK-STAT Signaling Pathway in Pyoderma Gangrenosum', 'organization': {'class': 'OTHER', 'fullName': 'Dokuz Eylul University'}, 'officialTitle': 'Expression of the JAK-STAT Signaling Pathway in Pyoderma Gangrenosum Pathological Biopsy', 'orgStudyIdInfo': {'id': 'DokuzEU-Rheumatology-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pyoderma Gangrenosum', 'description': 'Skin biopsies obtained from patients with pyoderma gangrenosum will be studied to evaluate JAK/STAT pathway by using immunohistochemical methods.', 'interventionNames': ['Diagnostic Test: immunohistochemical methods']}, {'label': 'Hidradenitis Suppurativa', 'description': 'Skin biopsies obtained from patients with hidradenitis suppurativa, will be studied to evaluate JAK/STAT pathway by using immunohistochemical methods', 'interventionNames': ['Diagnostic Test: immunohistochemical methods']}, {'label': 'Psoriasis', 'description': 'Skin biopsies obtained from patients with psoriasis, will be studied to evaluate JAK/STAT pathway by using immunohistochemical methods', 'interventionNames': ['Diagnostic Test: immunohistochemical methods']}, {'label': 'Healthy Subjects', 'description': 'Skin biopsies obtained from patients with healthy subjects, will be used to control group.', 'interventionNames': ['Diagnostic Test: immunohistochemical methods']}], 'interventions': [{'name': 'immunohistochemical methods', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['Healthy Subjects', 'Hidradenitis Suppurativa', 'Psoriasis', 'Pyoderma Gangrenosum']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ismail Sari, M.Sc', 'role': 'CONTACT', 'email': 'ismailsari35@gmail.com', 'phone': '+902324122222'}, {'name': 'Tuba Demirci Yıldırım, M.D.', 'role': 'CONTACT', 'email': 'tubademirci87@gmail.com', 'phone': '+902324122222'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dokuz Eylul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Doctor', 'investigatorFullName': 'Ismail Sari', 'investigatorAffiliation': 'Dokuz Eylul University'}}}}