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Recruiting NCT07860411

Metabolic and Immunologic Biomarkers in Chronic Rhinosinusitis With Nasal Polyps

Conditions: Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), Nasal Polyps

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 80
Sponsor: Harran University

Location: Harran University Faculty of Medicine Hospital, Department of Otorhinolaryngology Sanliurfa Şanlıurfa

Summary

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/MS) for free amino acid and carnitine/acylcarnitine 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.

Eligibility Criteria

CRSwNP Group Inclusion Criteria: * Age 18 years or older * Diagnosis of chronic rhinosinusitis with nasal polyps at the Otorhinolaryngology outpatient clinic * Diagnosis of nasal polyposis confirmed by histopathological examination of a punch biopsy or surgical specimen * No condition preventing the collection of tissue and peripheral blood samples within the scope of the study Exclusion Criteria: * Acute upper respiratory tract infection or acute rhinosinusitis * History of systemic inflammatory or autoimmune disease * History of malignancy or active malignant disease * Immunodeficiency or use of immunosuppressive therapy * Use of systemic corticosteroids, biologic agents or immunomodulatory therapy within the last 4 weeks * Use of antibiotics for an acute infection within the last 4 weeks * Pregnancy or breastfeeding * Presence of an additional systemic disease severe enough to prevent participation in the study Control Group Inclusion Criteria: * Age 18 years or older * No history of nasal polyposis or chronic rhinosinusitis * Scheduled for septoplasty, rhinoplasty or similar nasal surgery for reasons other than nasal polyps * Collection of a healthy nasal mucosa biopsy during surgery poses no additional risk Exclusion Criteria: \* Same exclusion criteria as the CRSwNP group

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07860411). StuddyBuddy aggregates publicly available trial information.