Investigation of Metabolic and Immunological Biomarkers in Tissue and Peripheral Blood of Patients With Chronic Rhinosinusitis With Nasal Polyposis
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Harran University Scientific Research Projects Coordination Unit
observational
80
1 country
1
Study Start
March 15, 2026
Actual (reported)Primary Completion
December 15, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 10, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 10, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 15, 2026
Actual (reported)October 1, 2026
Actual (reported)October 6, 2026
Actual (reported)December 15, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 10, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Tissue and serum free amino acid and carnitine/acylcarnitine profiles
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.
At the time of tissue sampling (Day 0)
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.
At the time of tissue sampling (Day 0)
Interleukin-6 (IL-6) levels in tissue and serum
At the time of tissue sampling (Day 0)
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 by punch biopsy in the outpatient clinic or during endoscopic sinus surgery, and a peripheral venous blood sample is collected at the same time. No additional intervention is applied.
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, and a peripheral venous blood sample is collected at the same time. No additional intervention is applied.
Nasal polyp tissue is obtained by punch biopsy in the outpatient clinic or during endoscopic sinus surgery, and a peripheral venous blood sample is collected at the same time. No additional intervention is applied.
A healthy nasal mucosa biopsy is obtained during septoplasty, rhinoplasty or similar nasal surgery, and a peripheral venous blood sample is collected at the same time. No additional intervention is applied.
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.
Harran University Faculty of Medicine Hospital, Department of Otorhinolaryngology
Sanliurfa, Şanlıurfa, 63300, Turkey (Türkiye)
Nasal tissue and peripheral blood (serum) samples.
Servet Erdemes, MD
Harran University
Mahmut Ağırtmış, MD
Harran University
First Submitted
October 1, 2026
First Posted
October 6, 2026
Study Start
March 15, 2026
Actual (reported)Primary Completion
December 15, 2026
EstimatedHypoxia-inducible factor-1 alpha (HIF-1α) levels in tissue and serum
At the time of tissue sampling (Day 0)
Diagnostic performance of candidate biomarkers
At the time of tissue sampling (Day 0)
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 10, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 19, 2026
Record last verified: 2026-10
Individual participant data will not be shared in order to protect participant confidentiality in accordance with national personal data protection regulations (KVKK).
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Source: ClinicalTrials.gov.
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