Viewing Study NCT01806220



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Last Modification Date: 2024-10-26 @ 11:04 AM
Study NCT ID: NCT01806220
Status: COMPLETED
Last Update Posted: 2015-03-20
First Post: 2012-08-29

Brief Title: Laryngeal and Esophageal EGF-r Expression in Patients With Reflux Laryngitis
Sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo
Organization: Faculdade de Ciências Médicas da Santa Casa de São Paulo

Study Overview

Official Title: Laryngeal and Esophageal EGF-r Expression in Patients With Reflux Laryngitis
Status: COMPLETED
Status Verified Date: 2015-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: EGFR
Brief Summary: Saliva plays an important role in the homeostasis of the digestive tract mucosa
Salivary organic components such as the Epidermal Growth FactorEGF have been found in defficient concentrations in patients with gastroesophageal reflux disease GERD and reflux related laryngitis LPR
The epidermal growth factor receptor EGFR signaling pathway is one of the most important pathways that regulate growth survival proliferation and differentiation in mammalian cells
Eperdermal growth factor receptor EGFR overexpression has been linked to hyperproliferative diseases
It is unknown if the inflammatory process in GERD is realated to difficiencies in EGFR expression
The objective of the current study was to try to establish a correlation between the expression of EGFR in the laryngeal and esophageal mucosa and the severity of laryngitis in adults with GERD and LPR
Detailed Description: Objectives The expression of the Epidermal Growth Factor receptor EGFR has been studied in a number of neoplastic and chronic diseases but there are no reports in literature regarding its expression in chronic laryngitis associated to Gastroesophageal Reflux isease GERD also known as Laryngopharyngeal Reflux LPR The current study compared the expression of EGFR in the esophageal and laryngeal mucosa of adults with GERD and LPR Study Design Prospective based on imunohistochemical analysis of parafine embedded biopsy specimens and clinical data Methods From August 2004 to February 2007 a total of 24 adults with confirmed diagnosis of LPR and no other clinical conditions or habits known to cause chronic laryngitis were studied at a University Hospital Biopsies of the distal esophagus and the retrocrycoid laryngeal mucosa were obtained during upper digestive endoscopy Data were analyzed statistically comparing samples in each individual and between individuals using the severity of histological signs of inflammation on hematoxacillin and eosinophillin HE stains to immunohistochemical analysis of the expression of EGFR Other independent variables were severity of symptoms and signs gender and age Fisherss exact test and multivariance ANOVA tests were used with significance level established at 95

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None