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