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Clinical Trials in Turkey / NCT07860411
Recruiting Observational

Metabolic and Immunologic Biomarkers in Chronic Rhinosinusitis With Nasal Polyps

NCT07860411 · tracked via the Priya Life Science Turkey tracker
Sponsor
Harran University
Phase
Observational
Started
2026-03-15
Last updated
2026-10-06

Condition(s) studied

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)Nasal Polyps

Investigational drug(s) / intervention(s)

Biospecimen collection

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Tissue and serum free amino acid and carnitine/acylcarnitine profiles — At the time of tissue sampling (Day 0)
    Concentrations of free amino acids, free carnitine and acylcarnitines measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS) in nasal tissue and serum, compared between the CRSwNP and control groups.
  • Interleukin-40 (IL-40) levels in tissue and serum — At the time of tissue sampling (Day 0)
    IL-40 concentrations measured by ELISA in nasal tissue and serum, compared between the CRSwNP and control groups.

Trial sites (1)

FacilityCityRegionStatus
Harran University Faculty of Medicine Hospital, Department of Otorhinolaryngology Sanliurfa Turkey (Türkiye) Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07860411 on ClinicalTrials.gov ↗ ← All trials in Turkey