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

NCT03250429 | Completed

• 1 other identifier: 17-1499
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

To characterize inflammatory cells in the nose of patients with Chronic Rhinosinusitis (CRS) before and after sinus surgery.

Conditions

Sinusitis, Chronic

Outcome Measures

Primary Outcomes (1)

• Change in Inflammatory mediators in the nasal mucosa

  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.

  Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)

Secondary Outcomes (4)

• Change in Inflammatory mediators in the peripheral blood

  Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)

• Change in Rhinosinusitis Disability Index (RSDI) Scores

  Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)

• Change in gene expression profile

  Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)

• Change in Nasal lavage fluid cell count

  Baseline (Pre-surgery), Post-surgery (approximately 12 weeks after surgery)

Study Arms (1)

CRS subjects

CRS subjects who have sinus surgery

Procedure: Sinus surgery

Interventions

Sinus surgery PROCEDURE

Standard Clinical Sinus Surgery

CRS subjects

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects who are patients at UNC Healthcare ENT clinics

You may qualify if:

• Physician diagnosed CRS with surgical requirement for treatment

You may not qualify if:

• Subjects with physician-diagnosed:
• cystic fibrosis,
• vasculitis,
• any type of nasal tumor
• receiving ongoing immunosuppressant therapy

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Flight Attendant Medical Research Institute: collaborator

Study Sites (1)

Center for Environmental Medicine, Asthma and Lung Biology

Chapel Hill, North Carolina, 27599, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, urine, nasal lavage fluid, nasal epithelial lining fluid

MeSH Terms

Conditions

Sinusitis; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Ilona Jaspers, Ph.D.

  UNC SOM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 15, 2017
• Study Start: September 1, 2017
• Primary Completion: December 10, 2018
• Study Completion: December 20, 2019
• Last Updated: February 5, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)