Nasal and Peripheral Blood Biomarkers of CRS Patients Before and After Surgical Intervention
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|ClinicalTrials.gov Identifier: NCT03250429|
Recruitment Status : Completed
First Posted : August 15, 2017
Last Update Posted : February 5, 2020
|Condition or disease||Intervention/treatment|
|Sinusitis, Chronic||Procedure: Sinus surgery|
Rhinosinusitis (RS) is a heterogenous disease, with variable etiologies, manifestations, and progression. Generally, RS can be divided into acute, subacute, and chronic RS, depending on the symptoms and duration of the disease. Most commonly, acute RS is caused by a viral infection (viral RS), which starts in the nasal passages and progresses to inflammation of the sinuses. When this inflammation of the paranasal sinuses does not resolve and lasts for at least 12 weeks, the disorder is broadly defined as chronic RS (CRS), which is usually accompanied by bacterial infections. This inflammatory disease pathophysiology is further subdivided into CRS with (CRSwNP) and without (CRSsNP) nasal polyps. Recently, several studies aimed at phenotyping the diverse pathophysiology among patients suffering from CRS characterized subgroups based on the presence of inflammatory clusters. CRSsNP is marked by pro-inflammatory neutrophilic inflammation of the nasal mucosa and a nasal cytokine profile that is characterized by increased levels of TGFβ1 and IFNγ and low or undetectable levels of IL-5. In contrast, patients with CRSwNP demonstrate eosinophilic inflammation of the nasal mucosa, low levels of TGFβ1, but high levels of Th2/Th17-type cytokines such as IL-17 and IL-5, higher levels of eosinophil cationic protein (ECP) and mast cell tryptase, and lower levels of IL-10.
Currently biomarkers associated with physician diagnosed disease severity and patient-perceived quality of life impairments are lacking. Analysis of markers of inflammation in the nasal mucosa and peripheral blood leukocytes in combination with quality of life symptom scoring will enable us to identify biomarkers associated with CRS disease severity. This study will determine if biomarkers identified in the nasal mucosa and peripheral blood leukocytes correlate with physician diagnosed and patient-perceived disease severity.
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Nasal and Peripheral Blood Biomarkers of CRS Patients Before and After Surgical Intervention|
|Actual Study Start Date :||September 1, 2017|
|Actual Primary Completion Date :||December 10, 2018|
|Actual Study Completion Date :||December 20, 2019|
CRS subjects who have sinus surgery
Procedure: Sinus surgery
Standard Clinical Sinus Surgery
- Change in Inflammatory mediators in the nasal mucosa [ Time Frame: Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery) ]Detection and analysis of inflammatory mediators previously characterized in CRS subgroups, including but not limited to Transforming growth factor beta 1 (TGFβ1), Interferon gamma (IFNγ), Interleukin 5 (IL-5), Interleukin 17 (IL-17), eosinophil cationic protein (ECP), mast cell tryptase, and Interleukin (IL-10) from the nasal mucosa.
- Change in Inflammatory mediators in the peripheral blood [ Time Frame: Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery) ]Detection and analysis of inflammatory mediators previously characterized in CRS subgroups, including but not limited to TGFβ1, IFNγ, IL-5, IL-17, ECP, mast cell tryptase, and IL-10 from the peripheral blood.
- Change in Rhinosinusitis Disability Index (RSDI) Scores [ Time Frame: Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery) ]The RSDI is a disease-specific health-related quality of life instrument with 3 domains (physical, functional, and emotional impacts of rhinosinusitis) using a 5-point Likert scale ranging from 0 to 4 where 0 is "never" and 4 is "always a problem". Higher scores indicate more significant impact on quality of life.
- Change in gene expression profile [ Time Frame: Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery) ]Analyze cells for gene expression of inflammatory mediators including but not limited to TGFβ1, IFNγ, IL-5, IL-17, ECP, mast cell tryptase, and IL-10
- Change in Nasal lavage fluid cell count [ Time Frame: Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery) ]Count cell types present in nasal lavage fluid cells.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03250429
|United States, North Carolina|
|Center for Environmental Medicine, Asthma and Lung Biology|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Ilona Jaspers, Ph.D.||UNC SOM|