Detection of Biomarker in Chronic Rhinosinusitis Patients by Analyzing Nasal Sinus Secretions and Tissue via Endoscopic Sinus Surgery

Overview

About this study

The purpose of this study is to determine if there is a difference in baseline nasal KLK1 level in patients with chronic rhinosinusitis, with or without nasal polyposis, versus normal controls (as obtained via nasal lavage or suctioning of nasal secretions), if the baseline KLK1 level is correlated to tissue KLK1 level (obtained during endoscopic nasal sinus surgery), and if tissue or nasal KLK1 level is associated with clinical presentation and/or therapeutic outcomes.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclujsion Criteria:

  • Subjects with chronic rhinosinusitis with nasal polyposis (CRSwNP).
  • Subjects with CRSwNP and aspirin sensitivity (aspirin-exacerbated respiratory disease, AERD).
  • Subjects with chronic rhinosinusitis without nasal polyposis (CRSsNP).  Chronic rhinosinusitis, with and without nasal polyposis, will be identified based upon sinus CT and/or nasal endoscopy.  Aspirin sensitivity will be assessed based upon clinical history.
  • Control subjects will be identified as patients do not have a history of concerning for chronic rhinosinusitis or who are seeking care in the Department of Otolaryngology or Division of Allergic Diseases for non-inflammatory sinus conditions (i.e. nasal septal deviation, headaches, etc.), asthma, or non-sinus-related issue.

Exclusion Criteria:

  • Subjects will be excluded from either the chronic rhinosinusitis or the control groups if they have chronic obstructive pulmonary disease (COPD).
  • Subjects who are current or recent smokers.
  • Subjects who have had recent use of systemic steroids (within 6 weeks).
  • Subjects who have underlying disorders which can cause sinusitis, such as cystic fibrosis, common variable immunodeficiency disease (CVID), hypereosinophilia, eosinophilic granulomatosis with polyangiitis (EGPA), or small vessel vasculitis, or who report to be pregnant at time of visit.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Rohit Divekar, M.B.B.S., Ph.D.

Closed-enrolling by invitation

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"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Kay Bachman R.N., C.C.R.C.

(507) 284-5689

bachman.kay@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20441972

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