Clinical trial NCT02270125: Nanoparticles in Nasal Mucosa
Official title: The Role of Nanoparticles in Inflammatory Changes of the Nasal Mucosa
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hypertrophic Rhinosinusitis
Chronic Polypous Rhinosinusitis
Keywords: nasal mucosa
chronic hypertrophic rhinosinusitis
mucotomy
nanoparticles
scanning electron microscopy
Raman microspectroscopy
nasal polyposis
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
Collaborators: name: VSB - Technical University of Ostrava
First posted: 2014-10-21
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with chronic hypertrophic rhinosinusitis, with or without polyposis Stillborn children

Brief summary: The aim of this prospective study is to evaluate presence and quantity of nano-sized particles and interindividual differences in their distribution and elemental composition in human nasal mucosa obtained by mucotomy in patients diagnosed with chronic hypertrophic rhinosinusitis and to compare the obtained results with control specimen obtained from stillborn children.

Detailed description: Samples of nasal mucosa are obtained by mucotomy in general anesthaesia from adult patients with chronic hypertrophic rhinosinusitis. Each tissue sample is divided into 4 parts based on the distance from the nostrils and is dehydrated, thinly sliced and mounted on glass slides. Then the tissue is analyzed with scanning electron microscopy (SEM) and Raman microspectroscopy (RMS) to detect solid particles and characterize the morphology and compositions of the detected particles. A novel method of quantification of distribution of the particles has been designed and used to evaluate interindividual differences in distribution of the particles. History of employment is obtained from the patients and the data are compared with the findings in the tissue samples.

The data acquired from the group of adult patients are compared with the results obtained from a group of control specimen of nasal mucosa harvested from stillborn children. It is presumed that no nano particles will be present in the stillborn children specimen since the mucosa was not exposed to airborne particles.

Eligibility criteria: Inclusion Criteria:

* chronic hypertrophic rhihosinusitis without polyposis non responsive to conservative treatment for at least six months
* chronic hypertrophic rhihosinusitis with polyposis non responsive to conservative treatment for at least six months
* age between 19 and 64 years of age
* signed informed consent of the patient
* stillborn children born after 28th week of gestation

Exclusion Criteria:

- non-signing of the informed consent

Primary outcomes:
measure: Detection and characterisation of nano particles
timeFrame: 36 months
Secondary outcomes:
measure: The presence of nano particles in the nasal mucosa obtained from stillborn children
timeFrame: 36 months
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: Nanotechnology Centre, VSB-Technical University Ostrava
state: Czech Republic
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Czech Republic
Study officials:
affiliation: University Hospital Ostrava, Medical Faculty of the Ostrava University
name: Lenka Čábalová, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zelenik K, Kukutschova J, Dvorackova J, Bielnikova H, Peikertova P, Cabalova L, Kominek P. Possible role of nano-sized particles in chronic tonsillitis and tonsillar carcinoma: a pilot study. Eur Arch Otorhinolaryngol. 2013 Feb;270(2):705-9. doi: 10.1007/s00405-012-2069-5. Epub 2012 Jun 8.
citation: Dvorackova J, Bielnikova H, Kukutschova J, Peikertova P, Filip P, Zelenik K, Kominek P, Uvirova M, Pradna J, Cermakova Z, Dvoracek I. Detection of nano- and micro-sized particles in routine biopsy material - pilot study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2015 Mar;159(1):87-92. doi: 10.5507/bp.2012.104. Epub 2012 Dec 10.
citation: Oberdorster G, Oberdorster E, Oberdorster J. Nanotoxicology: an emerging discipline evolving from studies of ultrafine particles. Environ Health Perspect. 2005 Jul;113(7):823-39. doi: 10.1289/ehp.7339.