The Factors Associated With the Formation of Nasal polyp-a Case Control and Descriptive Study
NCT ID: NCT01278719
Last Updated: 2012-04-23
Study Results
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Basic Information
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UNKNOWN
180 participants
OBSERVATIONAL
2010-01-31
2013-06-30
Brief Summary
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Etiology is largely unknown despite the disease being present for centuries. Although the factors like wood stove exposure, smoking, allergic rhinitis, rhino sinusitis have been strongly implicated in literature from various studies, most data available is on ethmoidal polyps.The present study is an attempt to study the association of important risk factors with both antrochoanal(AC) and ethmoidal nasal polyps(EP).One study found that a significantly smaller proportion of the population with polyps were smokers compared to the unselected population (15% v/s 35%). But this is not confirmed by other studies.
Seven percent of asthma patients have nasal polyps and in non atopic asthma and late onset asthma, polyps are diagnosed more frequently (10-15%).Eosinophil numbers are significantly higher in nasal polyp tissue and further increased in patients with co-morbid asthma and aspirin sensitivity.
Nasal colonization in increased amounts was found by Staphylococcus aureus and presence of specific Immunoglobulin E directed against S.aureus enterotoxins was found. Rates of colonization and IgE presence in nasal polyp tissue were increased in subjects with nasal polyp associated with co-morbid asthma and aspirin sensitivity.
Nasal polyps are frequently found to run in families, suggesting a hereditary or with shared environmental factor. In the study by Rugina et al., more than half of 224 nasal polyp patients (52%) had a positive family history while the study by Greisener et.al, reported 14% of family history strongly suggesting hereditary factors in the pathogenesis of nasal polyps.
Some studies have found environmental factors like smoking and those using wood stove as a primary source of heating with the development of nasal polyps. The studies are contrasting.
There is presently a need of understanding the differences in the pathogenesis of antrochoanal polyp and ethmoidal nasal polyp clearly.There are hardly any concrete research performed on them to note the differences in the etiology and their pathogenesis. Hence the study is undertaken to extensively study the etiologies responsible for them and to note the differences.
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Detailed Description
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A descriptive study focuses on the nasal polyp occurrence with respect to the age, sex, religion, socioeconomic status, urban or rural preponderance,overcrowding, aspirin intolerance, family history etc.
The results will be studies after calculating the odds ratio and the chi square test for whatever data is available. Interpretation will be performed subsequently.
Gene expression profiling would be performed to study the differences in gene expression levels between AC and EP s with respect to risk factors and morphological characteristics.Mutational analysis will be performed to identify mutations in selected genes.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Antrochaonal polyp; non recurrent type
No interventions assigned to this group
Antrochoanal polyp; recurrent type
No interventions assigned to this group
Ethmoidal polyp - non recurrent type
No interventions assigned to this group
Ethmoidal polyp - recurrent type
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Recurrent nasal polyps
3. Both infected and non infected polyps
4. Both eosinophilic and non eosinophilic polyps
Exclusion Criteria
2. Immunodeficiency status like HIV
ALL
Yes
Sponsors
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Ministry of Science and Technology, India
OTHER_GOV
Applied Genetics
INDUSTRY
Lab Discoveries Ltd.
INDUSTRY
Karnataka Institute of Medical Sciences
OTHER
Responsible Party
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Manjunath dandinarasaiah
Department of ENT
Principal Investigators
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Dr.Manjunath D Narasaiah, MS
Role: PRINCIPAL_INVESTIGATOR
Assistant Professor in ENT, Karnataka Institute of Medical Sciences, Hubli-580021, Karnataka, India
Locations
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Department of Otorhinolaryngology, Karnataka Institute of Medical Sciences
Hubli, Karnataka, India
Countries
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Central Contacts
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Facility Contacts
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References
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Videler WJ, van Drunen CM, van der Meulen FW, Fokkens WJ. Radical surgery: effect on quality of life and pain in chronic rhinosinusitis. Otolaryngol Head Neck Surg. 2007 Feb;136(2):261-7. doi: 10.1016/j.otohns.2006.08.010.
Hedman J, Kaprio J, Poussa T, Nieminen MM. Prevalence of asthma, aspirin intolerance, nasal polyposis and chronic obstructive pulmonary disease in a population-based study. Int J Epidemiol. 1999 Aug;28(4):717-22. doi: 10.1093/ije/28.4.717.
Rugina M, Serrano E, Klossek JM, Crampette L, Stoll D, Bebear JP, Perrahia M, Rouvier P, Peynegre R. Epidemiological and clinical aspects of nasal polyposis in France; the ORLI group experience. Rhinology. 2002 Jun;40(2):75-9.
Kim J, Hanley JA. The role of woodstoves in the etiology of nasal polyposis. Arch Otolaryngol Head Neck Surg. 2002 Jun;128(6):682-6. doi: 10.1001/archotol.128.6.682.
Greisner WA 3rd, Settipane GA. Hereditary factor for nasal polyps. Allergy Asthma Proc. 1996 Sep-Oct;17(5):283-6. doi: 10.2500/108854196778662192.
Settipane GA, Chafee FH. Nasal polyps in asthma and rhinitis. A review of 6,037 patients. J Allergy Clin Immunol. 1977 Jan;59(1):17-21. doi: 10.1016/0091-6749(77)90171-3.
Other Identifiers
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KIMSPGS412
Identifier Type: -
Identifier Source: org_study_id
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