Metabolic and Immunologic Biomarkers in Chronic Rhinosinusitis With Nasal Polyps
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHarran University
About this trial
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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Biospecimen collection
Other interventionCollection 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: CRSwNP Group1 intervention
Group B: Control Group1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
At the time of tissue sampling (Day 0)2
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.
Time frame
At the time of tissue sampling (Day 0)Secondary outcomes
1
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.
Time frame
At the time of tissue sampling (Day 0)2
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.
Time frame
At the time of tissue sampling (Day 0)3
Diagnostic performance of candidate biomarkers
Area under the receiver operating characteristic curve (AUC), sensitivity and specificity of tissue and serum amino acid, carnitine/acylcarnitine, IL-40, IL-6 and HIF-1α levels for discriminating CRSwNP from control subjects.
Time frame
At the time of tissue sampling (Day 0)Sponsors and contacts
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Source ClinicalTrials.gov