Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)NCT07860411
Metabolic and Immunologic Biomarkers in Chronic Rhinosinusitis With Nasal Polyps
An observational study of Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) and Nasal Polyps, run by Harran University at 1 site in Turkey (Türkiye).
Trial summary
Chronic rhinosinusitis with nasal polyps (CRSwNP) is a heterogeneous inflammatory disease of the sinonasal mucosa whose metabolic and immunologic mechanisms are incompletely understood. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), Nasal Polyps
- What is being tested?
- Nasal polyp tissue and blood sampling and Nasal mucosa and blood sampling
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2026to 10 Mar 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study 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.
Who may be able to join
- 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
- 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
Who cannot join
- 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
Show all 10Show fewer
- Pregnancy or breastfeeding
- Presence of an additional systemic disease severe enough to prevent participation in the study
- Control Group
- Same exclusion criteria as the CRSwNP group
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Harran University Faculty of Medicine Hospital, Department of Otorhinolaryngology
Sanliurfa, Şanlıurfa, 63300
Mahmut Ağırtmış, MD, +905012392163, mahmutagirtmis@harran.edu.tr
About this study
Official title: Investigation of Metabolic and Immunological Biomarkers in Tissue and Peripheral Blood of Patients With Chronic Rhinosinusitis With Nasal Polyposis
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.
Read the detailed description
Adult patients presenting to the Otorhinolaryngology outpatient clinic of Harran University Faculty of Medicine with nasal obstruction and a histopathologically confirmed diagnosis of nasal polyposis (by punch biopsy or surgical specimen) will be enrolled. Nasal polyp tissue and peripheral blood samples will be collected from 40 patients with CRSwNP. The control group will consist of 40 patients undergoing septoplasty, rhinoplasty or similar nasal surgery for reasons other than nasal polyps, from whom healthy nasal mucosa biopsies and peripheral blood samples will be obtained. Free amino acid and carnitine/acylcarnitine profiles will be determined in tissue and serum by LC-MS/MS, and IL-40, IL-6 and HIF-1α concentrations will be measured by ELISA. Metabolic and immunologic differences between nasal polyp tissue and healthy nasal mucosa, and their reflection in peripheral blood, will be compared between groups. Tissue and blood levels obtained from the same individual will be compared using paired tests, and correlations between metabolic parameters and immune markers will be assessed by Pearson or Spearman correlation analysis. In the CRSwNP group, associations of these biomarkers with disease severity, symptom scores and endoscopic findings will also be evaluated. The diagnostic performance of candidate biomarkers will be assessed by receiver operating characteristic (ROC) analysis. To our knowledge, IL-40 has not previously been investigated in CRSwNP.
- Being tested
- Nasal polyp tissue and blood sampling, Nasal mucosa and blood sampling
- Keywords
- Metabolomics, LC-MS/MS, Interleukin-40, Interleukin-6, HIF-1 alpha, Biomarkers, Amino acids, Acylcarnitines
- Medical subject headings
- Nasal Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal polyp tissue and blood samplingOther
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.
Nasal mucosa and blood samplingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| CRSwNP Group | 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. Receives: Other: Nasal polyp tissue and blood sampling | |
| Control Group | 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. Receives: Other: Nasal mucosa and blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: At the time of tissue sampling (Day 0)
Secondary outcomes (3)
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.
Measured: At the time of tissue sampling (Day 0)
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.
Measured: At the time of tissue sampling (Day 0)
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.
Measured: At the time of tissue sampling (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start15 Mar 2026
- Primary completion15 Dec 2026 (estimated)
- Study completion10 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Harran University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Servet Erdemes, Harran University
- Investigators
- Servet Erdemes, MD, Principal investigator, Harran UniversityMahmut Ağırtmış, MD, Study director, Harran University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860411
- Sponsor's protocol ID
- HRÜ26.03.14
- Other IDs
- 26092
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared in order to protect participant confidentiality in accordance with national personal data protection regulations (KVKK).