[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591522":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":15,"centralContacts":20,"locations":26,"responsibleParty":42,"collaborators":10,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":60,"studyType":61,"phases":10,"briefSummary":62,"conditions":63,"keywords":10,"overallStatus":68,"whyStopped":10,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"Hitit University","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Grup 1: Group Title: FMF Patients Group\u002FCohort Label: FMF",null,"1\\. FMF Patients (Group\u002FCohort Description) Patients diagnosed with Familial Mediterranean Fever (FMF) according to clinical criteria and\u002For genetic analysis. Intestinal mucosal biopsy samples were obtained during routine endoscopy, and immunohistochemical staining for IL-1, IL-18, and Caspase-1 was performed.",{"label":13,"type":10,"description":14,"interventionNames":10},"Grup 2: Group Title: Healthy Controls Group\u002FCohort Label: Control","2\\. Healthy Controls (Group\u002FCohort Description) Healthy individuals without any known inflammatory or autoimmune disease, undergoing endoscopy for non-inflammatory indications such as functional gastrointestinal symptoms. Mucosal biopsy samples were collected and analyzed immunohistochemically for IL-1, IL-18, and Caspase-1 expression.",[16],{"name":17,"affiliation":18,"role":19},"Mustafa Şahin, Assoc.Prof","Hitit University Faculty of Medicine, Turkey","PRINCIPAL_INVESTIGATOR",[21],{"name":17,"role":22,"phone":23,"phoneExt":24,"email":25},"CONTACT","+90 364 219 30 00","2722","sahinmustafa@hitit.edu.tr",[27],{"facility":28,"status":10,"city":29,"state":10,"zip":30,"country":31,"countryCode":10,"cosmosGeoPoint":32,"geoPoint":37,"contacts":38},"Hitit University Erol Olçok Training and Research Hospital","Çorum","19040","Turkey (Türkiye)",{"type":33,"coordinates":34},"Point",[35,36],34.95333,40.54889,{"lat":36,"lon":35},[39],{"name":40,"role":22,"phone":23,"phoneExt":24,"email":41},"Mustafa Şahin, Assoc. Prof.","mustafaistanbulx@hotmail.com",{"type":19,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Mustafa Sahin","Principal Investigator, Associate Professor of Medical Biochemistry","100591522","caspase-1-activity-il-1beta-and-il-18-in-patients-with-fmf-100591522",false,"NCT06981520","Caspase-1 Activity, IL-1beta, and IL-18 in Patients With FMF","Effect of Caspase-1 Activity, IL-1beta, and IL-18 on Inflammation in the Mucosa of the Small Intestine of Patients With FMF","FMF","Inclusion Criteria:Age 18 years or older\n\nConfirmed diagnosis of Familial Mediterranean Fever (FMF) according to Tel-Hashomer clinical criteria and\u002For MEFV gene mutation analysis (for FMF group)\n\nUndergoing routine endoscopy with mucosal biopsy sampling\n\nAvailability of sufficient formalin-fixed paraffin-embedded (FFPE) tissue for immunohistochemical analysis\n\nFor controls: absence of systemic inflammatory or autoimmune disease -\n\nExclusion Criteria:History of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)\n\nCurrent use of immunosuppressive therapy (excluding colchicine)\n\nSevere infection, active malignancy, or other systemic disease affecting intestinal mucosa\n\nInadequate biopsy specimen quality for histopathological evaluation\n\n\\-",true,"ALL","18 Years","55 Years",{"count":58,"type":59},30,"ESTIMATED","8 Months","OBSERVATIONAL","This study aims to investigate the intestinal mucosal expression of key inflammatory markers, namely Interleukin-1 (IL-1), Interleukin-18 (IL-18), and Caspase-1, in patients with Familial Mediterranean Fever (FMF). FMF is an autoinflammatory disorder characterized by recurrent episodes of fever and serosal inflammation. Recent studies suggest a possible role of intestinal immune activation in the disease pathogenesis, particularly through inflammasome-related cytokines. To better understand mucosal involvement in FMF, immunohistochemical staining for IL-1, IL-18, and Caspase-1 will be performed on intestinal biopsy samples obtained during routine endoscopic procedures. The staining intensity and distribution patterns will be evaluated and compared with age- and sex-matched healthy controls. The findings may help clarify mucosal inflammatory pathways involved in FMF and provide insight into novel therapeutic targets.",[64,65,66,67],"Familial Mediterranean Fever","Intestinal Disease","Genetic Disease","Fever","NOT_YET_RECRUITING","2025-05-13",{"date":71,"type":72},"2025-05-20","ACTUAL",{"date":74,"type":59},"2025-07-10",{"date":76,"type":59},"2026-01-19",{"name":5,"class":6},1]