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Nasal and Peripheral Blood Biomarkers of CRS Patients Before and After Surgical Intervention

This study is currently recruiting participants.
See Contacts and Locations
Verified September 2017 by University of North Carolina, Chapel Hill
Sponsor:
Collaborator:
Flight Attendant Medical Research Institute
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT03250429
First received: August 10, 2017
Last updated: September 13, 2017
Last verified: September 2017
  Purpose
To characterize inflammatory cells in the nose of patients with Chronic Rhinosinusitis (CRS) before and after sinus surgery.

Condition Intervention
Sinusitis, Chronic Procedure: Sinus surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Nasal and Peripheral Blood Biomarkers of CRS Patients Before and After Surgical Intervention

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
Whole blood, urine, nasal lavage fluid, nasal epithelial lining fluid

Estimated Enrollment: 100
Actual Study Start Date: September 1, 2017
Estimated Study Completion Date: August 21, 2019
Estimated Primary Completion Date: August 21, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
CRS subjects
CRS subjects who have sinus surgery
Procedure: Sinus surgery
Standard Clinical Sinus Surgery

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who are patients at UNC Healthcare ENT clinics
Criteria

Inclusion Criteria:

  • Physician diagnosed CRS with surgical requirement for treatment

Exclusion Criteria:

  • Subjects with physician-diagnosed:
  • cystic fibrosis,
  • vasculitis,
  • any type of nasal tumor
  • receiving ongoing immunosuppressant therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03250429

Contacts
Contact: Martha Almond 919-966-0759 martha_almond@med.unc.edu

Locations
United States, North Carolina
Center for Environmental Medicine, Asthma and Lung Biology Recruiting
Chapel Hill, North Carolina, United States, 27599
Principal Investigator: Ilona Jaspers, PhD         
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Flight Attendant Medical Research Institute
Investigators
Principal Investigator: Ilona Jaspers, Ph.D. UNC SOM
  More Information

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03250429     History of Changes
Other Study ID Numbers: 17-1499
Study First Received: August 10, 2017
Last Updated: September 13, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 21, 2017