[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659209":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":30,"studyPopulation":31,"armGroups":32,"interventions":42,"overallOfficials":47,"centralContacts":54,"locations":59,"responsibleParty":74,"collaborators":26,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":26,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":26,"enrollmentInfo":87,"targetDuration":26,"studyType":90,"phases":26,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":62,"whyStopped":26,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Harran University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":26},[9,13],{"measure":10,"description":11,"timeFrame":12},"Tissue and serum free amino acid and carnitine\u002Facylcarnitine profiles","Concentrations of free amino acids, free carnitine and acylcarnitines measured by liquid chromatography-tandem mass spectrometry (LC-MS\u002FMS) in nasal tissue and serum, compared between the CRSwNP and control groups.","At the time of tissue sampling (Day 0)",{"measure":14,"description":15,"timeFrame":12},"Interleukin-40 (IL-40) levels in tissue and serum","IL-40 concentrations measured by ELISA in nasal tissue and serum, compared between the CRSwNP and control groups.",[17,20,23],{"measure":18,"description":19,"timeFrame":12},"Interleukin-6 (IL-6) levels in tissue and serum","IL-6 concentrations measured by ELISA in nasal tissue and serum, compared between the CRSwNP and control groups.",{"measure":21,"description":22,"timeFrame":12},"Hypoxia-inducible factor-1 alpha (HIF-1α) levels in tissue and serum","HIF-1α concentrations measured by ELISA in nasal tissue and serum, compared between the CRSwNP and control groups.",{"measure":24,"description":25,"timeFrame":12},"Diagnostic performance of candidate biomarkers","Area under the receiver operating characteristic curve (AUC), sensitivity and specificity of tissue and serum amino acid, carnitine\u002Facylcarnitine, IL-40, IL-6 and HIF-1α levels for discriminating CRSwNP from control subjects.",null,{"allocation":26,"interventionModel":26,"interventionModelDescription":26,"primaryPurpose":26,"observationalModel":28,"timePerspective":29,"maskingInfo":26},"CASE_CONTROL","PROSPECTIVE","Adult patients presenting to the Otorhinolaryngology outpatient clinic of Harran University Faculty of Medicine with nasal obstruction and a histopathologically confirmed diagnosis of nasal polyposis (by punch biopsy or surgical specimen) will be enrolled. Nasal polyp tissue and peripheral blood samples will be collected from 40 patients with CRSwNP. The control group will consist of 40 patients undergoing septoplasty, rhinoplasty or similar nasal surgery for reasons other than nasal polyps, from whom healthy nasal mucosa biopsies and peripheral blood samples will be obtained. Free amino acid and carnitine\u002Facylcarnitine profiles will be determined in tissue and serum by LC-MS\u002FMS, and IL-40, IL-6 and HIF-1α concentrations will be measured by ELISA. Metabolic and immunologic differences between nasal polyp tissue and healthy nasal mucosa, and their reflection in peripheral blood, will be compared between groups. Tissue and blood levels obtained from the same individual will be compared using paired tests, and correlations between metabolic parameters and immune markers will be assessed by Pearson or Spearman correlation analysis. In the CRSwNP group, associations of these biomarkers with disease severity, symptom scores and endoscopic findings will also be evaluated. The diagnostic performance of candidate biomarkers will be assessed by receiver operating characteristic (ROC) analysis. To our knowledge, IL-40 has not previously been investigated in CRSwNP.","Adult patients presenting with nasal obstruction to the Otorhinolaryngology outpatient clinic of Harran University Faculty of Medicine, Şanlıurfa, Turkey, with histopathologically confirmed chronic rhinosinusitis with nasal polyps (by punch biopsy or surgical specimen), and adult control patients without chronic rhinosinusitis scheduled for septoplasty, rhinoplasty or similar nasal surgery at the same department.",[33,38],{"label":34,"type":26,"description":35,"interventionNames":36},"CRSwNP Group","Adult patients diagnosed with chronic rhinosinusitis with nasal polyps according to EPOS 2020 criteria, with nasal polyposis confirmed histopathologically by punch biopsy or surgical specimen. Nasal polyp tissue is obtained either by punch biopsy in the outpatient clinic or during endoscopic sinus surgery.",[37],"Other: Biospecimen collection",{"label":39,"type":26,"description":40,"interventionNames":41},"Control Group","Adult patients without nasal polyposis or chronic rhinosinusitis scheduled for septoplasty, rhinoplasty or similar nasal surgery for reasons other than nasal polyps. A healthy nasal mucosa biopsy is obtained during surgery.",[37],[43],{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":26},"Biospecimen collection","Collection of nasal tissue (by outpatient punch biopsy or during surgery) and a peripheral blood sample at the time of tissue sampling; no additional intervention is applied.",[34,39],[48,51],{"name":49,"affiliation":5,"role":50},"Servet Erdemes, MD","PRINCIPAL_INVESTIGATOR",{"name":52,"affiliation":5,"role":53},"Mahmut Ağırtmış, MD","STUDY_DIRECTOR",[55],{"name":52,"role":56,"phone":57,"phoneExt":26,"email":58},"CONTACT","+905012392163","mahmutagirtmis@harran.edu.tr",[60],{"facility":61,"status":62,"city":63,"state":26,"zip":64,"country":65,"countryCode":26,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Harran University Faculty of Medicine Hospital, Department of Otorhinolaryngology","RECRUITING","Sanliurfa","63300","Turkey (Türkiye)",{"type":67,"coordinates":68},"Point",[69,70],38.79392,37.16708,{"lat":70,"lon":69},[73],{"name":52,"role":56,"phone":57,"phoneExt":26,"email":58},{"type":50,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Servet Erdemes","Assistant Professor of Otorhinolaryngology","100659209","metabolic-and-immunologic-biomarkers-in-chronic-rhinosinusitis-with-nasal-polyps-100659209",false,"NCT07860411","Metabolic and Immunologic Biomarkers in Chronic Rhinosinusitis With Nasal Polyps","Investigation of Metabolic and Immunological Biomarkers in Tissue and Peripheral Blood of Patients With Chronic Rhinosinusitis With Nasal Polyposis","CRSwNP Group\n\nInclusion Criteria:\n\n* Age 18 years or older\n* Diagnosis of chronic rhinosinusitis with nasal polyps at the Otorhinolaryngology outpatient clinic\n* Diagnosis of nasal polyposis confirmed by histopathological examination of a punch biopsy or surgical specimen\n* No condition preventing the collection of tissue and peripheral blood samples within the scope of the study\n\nExclusion Criteria:\n\n* Acute upper respiratory tract infection or acute rhinosinusitis\n* History of systemic inflammatory or autoimmune disease\n* History of malignancy or active malignant disease\n* Immunodeficiency or use of immunosuppressive therapy\n* Use of systemic corticosteroids, biologic agents or immunomodulatory therapy within the last 4 weeks\n* Use of antibiotics for an acute infection within the last 4 weeks\n* Pregnancy or breastfeeding\n* Presence of an additional systemic disease severe enough to prevent participation in the study\n\nControl Group\n\nInclusion Criteria:\n\n* Age 18 years or older\n* No history of nasal polyposis or chronic rhinosinusitis\n* Scheduled for septoplasty, rhinoplasty or similar nasal surgery for reasons other than nasal polyps\n* Collection of a healthy nasal mucosa biopsy during surgery poses no additional risk\n\nExclusion Criteria:\n\n\\* Same exclusion criteria as the CRSwNP group",true,"ALL","18 Years",{"count":88,"type":89},80,"ESTIMATED","OBSERVATIONAL","Chronic rhinosinusitis with nasal polyps (CRSwNP) is a heterogeneous inflammatory disease of the sinonasal mucosa whose metabolic and immunologic mechanisms are incompletely understood. This prospective case-control study aims to characterize metabolic and immunologic biomarkers in patients with CRSwNP compared with control subjects. Nasal tissue and peripheral blood samples will be analyzed by liquid chromatography-tandem mass spectrometry (LC-MS\u002FMS) for free amino acid and carnitine\u002Facylcarnitine profiles, and levels of interleukin-40 (IL-40), interleukin-6 (IL-6), and hypoxia-inducible factor-1 alpha (HIF-1α) will be measured by ELISA. The findings are expected to contribute to understanding disease pathogenesis and to identifying potential diagnostic biomarkers and therapeutic targets.",[93,94],"Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)","Nasal Polyps",[96,97,98,99,100,101,102,103],"Metabolomics","LC-MS\u002FMS","Interleukin-40","Interleukin-6","HIF-1 alpha","Biomarkers","Amino acids","Acylcarnitines","2026-10-01",{"date":106,"type":107},"2026-10-06","ACTUAL",{"date":109,"type":107},"2026-03-15",{"date":111,"type":89},"2027-03-10",{"name":5,"class":6},1]