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Associations between immune and genetic imbalances and risk factors in patients with chronic rhinosinusitis

Associations between phenotypic and endotypic groups, risk factors, immune imbalances, and genetic alterations in patients with chronic rhinosinusitis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN36938545
Enrollment
300
Registered
2024-12-24
Start date
2023-10-26
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic rhinosinusitis Ear, Nose and Throat

Interventions

The study will include patients diagnosed with CRS (chronic rhinosinusitis) based on the 2020 EPOS criteria. These patients will be divided into two phenotypic groups: CRSwNP (chronic rhinosinusitis w

Sponsors

Lithuanian University of Health Sciences, LSMU
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with CRS: 1. Based on the 2020 EPOS criteria, a CRS diagnosis was established, and the patient underwent endonasal sinus surgery. 2. Presence of two or more symptoms: nasal obstruction/difficulty breathing through the nose, nasal discharge/postnasal drip, and/or facial pain or pressure, and/or loss or reduction of the sense of smell. 3. Endoscopic findings (polyps, mucopurulent discharge in the middle nasal meatus, mucosal swelling—edema causing obstruction, primarily in the middle nasal meatus); changes visible in computed tomography scans (bony canal and ostiomeatal complex changes and/or sinus mucosal changes). Healthy (Control) Participants: 1. Individuals without CRS received treatment for conditions not related to CRS, such as skull base lesions, lacrimal sac or orbital issues, and nasal septum defects. General Criteria: 1. Individuals who are 18 or older and meet the criteria mentioned above. 2. Participants are willing to take part in the study voluntarily. 3. Individuals who have read and signed the informed consent form and the genetic testing consent form.

Exclusion criteria

Exclusion criteria: 1. Individuals under 18 years of age 2. Individuals for whom venous puncture is contraindicated or poses a risk of complications 3. Individuals who have not read or signed the informed consent form 4. Pregnant women 5. Individuals with autoimmune diseases 6. Individuals with diabetes mellitus 7. Individuals with chronic lung diseases, such as cystic fibrosis, chronic obstructive pulmonary disease (COPD), or similar conditions 8. Individuals with Wegener's granulomatosis

Design outcomes

Primary

MeasureTime frame
Measured on the day of surgery: 1. The concentrations of IL-1, IL-2, IL-4, IL-5, IL-6, IL-7, IL-10, IL-12, IL-13, IL-17, IL-21, IL-22, IFN-?, and TNF-a (in pg/ml) will be measured in tissue and serum samples using the flow cytometry-based Luminex method, which allows simultaneous detection of all investigated marker concentrations. 2. Gene polymorphism analysis in blood samples will use allele-specific primers based on the competitive allele-specific PCR (KASP) reaction methodology. The polymerase chain reaction (PCR) method will be used to determine differences in the gene expression of miRNA in plasma, TGF-ß, and Wnt signaling pathways, extracellular matrix proteins, and their regulatory molecules in postoperative tissue samples.

Secondary

MeasureTime frame
Measured on the day of surgery: 1. Complete blood count test 2. Histology of biopsy material 3. Citology tests 4. Assessing the quality of life using the SNOT-22 questionnaire

Countries

Lithuania

Contacts

Public ContactZygimantas;Ieva Vaitkus;Janulaityte

;

zygimantas.vaitkus@lsmu.lt;ieva.janulaityte@lsmuni.lt+370 (0)63861378;+370 (0)61132314

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026