Metabolic and Immunologic Biomarkers in Chronic Rhinosinusitis with Nasal Polyps

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective case-control study compares adults with CRSwNP to control patients without polyps. Researchers will analyze nasal tissue and blood for amino acids, carnitine profiles, and levels of IL-40, IL-6, and HIF-1α using LC-MS/MS and ELISA. They will examine differences between diseased tissue and healthy mucosa, and explore how these biomarkers relate to disease severity and symptoms. The study also assesses how well the biomarkers discriminate between CRSwNP and non-polyp controls through ROC analysis. IL-40 is explored as a novel biomarker in CRSwNP for the first time.

Why it matters

Who can join: the full rules

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

Where it's running

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

Study contacts

• Principal investigator: Servet Erdemes, MD — Harran University
• Study coordinator: Mahmut Ağırtmış, MD
• Email: mahmutagirtmis@harran.edu.tr
• Phone: +905012392163

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• GSK5784283 as add-on therapy for chronic rhinosinusitis with nasal polyps

  This study tests whether GSK5784283 added to standard care can help adults with chronic rhinosinusitis with nasal polyps feel better and have fewer symptoms.

  Recruiting at 8 sites Phase 3 GlaxoSmithKline · Los Angeles, California and 7 other locations · NCT07782970

• GSK5784283 as add-on maintenance therapy for nasal polyps in chronic rhinosinusitis

  This study tests whether adding GSK5784283 (Felcorekibart) to standard care helps people with chronic rhinosinusitis with nasal polyps.

  Recruiting at 4 sites Phase 3 GlaxoSmithKline · Sherman Oaks, California and 3 other locations · NCT07782957

• Triamcinolone-loaded nanocapsules after endoscopic nasal surgery

  This trial tests whether a triamcinolone acetonide–loaded nanocapsule spray is better than saline irrigation for healing after endoscopic nasal surgery in adults with chronic rhinosinusitis and nasal polyps.

  Recruiting Phase 2 Deraya University · Minya, Menia Governorate · NCT07714525

• Depemokimab monotherapy for chronic rhinosinusitis with nasal polyps in Japanese adults

  This study tests depemokimab alone (without intranasal corticosteroids) in adults with chronic rhinosinusitis with nasal polyps in Japan.

  Recruiting at 10 sites Phase 4 GlaxoSmithKline · Ehime and 9 other locations · NCT07701967

• Tezepelumab in real-world CRSwNP: a real-world look at patient outcomes

  This study tests tezepelumab in adults with chronic rhinosinusitis with nasal polyps to see how their symptoms and daily life change in routine care over about two years.

  Recruiting at 19 sites AstraZeneca · Berlin and 18 other locations · NCT07633158

• BBT002 in healthy adults and in people with chronic rhinosinusitis with nasal polyps

  This study tests BBT002 versus placebo to see how it acts, how safe it is, and whether it helps people with chronic rhinosinusitis with nasal polyps, with or without asthma.

  Recruiting at 12 sites Phase 1/2 Bambusa Therapeutics · Beijing, Beijing Municipality and 11 other locations · NCT07436949

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.