Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT01806220
Status:
COMPLETED
Last Update Posted:
2015-03-20
First Post:
2012-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Laryngeal and Esophageal EGF-r Expression in Patients With Reflux Laryngitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005764', 'term': 'Gastroesophageal Reflux'}], 'ancestors': [{'id': 'D015154', 'term': 'Esophageal Motility Disorders'}, {'id': 'D003680', 'term': 'Deglutition Disorders'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-18', 'studyFirstSubmitDate': '2012-08-29', 'studyFirstSubmitQcDate': '2013-03-06', 'lastUpdatePostDateStruct': {'date': '2015-03-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Epidermal Growth Factor Receptor (EGFR) expression in laryngeal and esophageal mucosa of patients with chronic reflux laryngitis', 'timeFrame': 'prospective study that enrolled every adult patient with reflux laryngitis and no other causes of chronic laryngeal and pharyngeal inflammation during a 36 month period', 'description': 'Patients with reflux laryngitis diagnosed by suggestive symptoms (Reflux Symptom Index\\>13) and videolaryngoscopic signs (Reflux Finding Score\\>7) and confirmed by a 24-hour double probe esophageal ph monitoring test were consecutively enrolled properly informed and consented.'}], 'secondaryOutcomes': [{'measure': 'Compare Epidermal Growth Factor Receptor expression in different severities of inflammatory responses.', 'timeFrame': 'EGFR expression of the esophageal and laryngeal mucosas was compared to clinical, videolaryngoscopic and microscopic inflammatory signs. (up to 36 months)', 'description': 'Mucosal biopsy specimens obtained during routine upper digestive tract endocopic examination under sedation were obtained.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Gastroesophageal Reflux Disease (GERD)', 'Chronic Laryngitis', 'Epidermal Growth factor receptor'], 'conditions': ['Gastroesophageal Reflux Disease', 'Chronic Laryngitis']}, 'referencesModule': {'references': [{'pmid': '15467608', 'type': 'BACKGROUND', 'citation': 'Eckley CA, Michelsohn N, Rizzo LV, Tadokoro CE, Costa HO. Salivary epidermal growth factor concentration in adults with reflux laryngitis. Otolaryngol Head Neck Surg. 2004 Oct;131(4):401-6. doi: 10.1016/j.otohns.2004.01.020.'}, {'pmid': '17589721', 'type': 'BACKGROUND', 'citation': 'Eckley CA, Rios Lda S, Rizzo LV. Salivary egf concentration in adults with reflux chronic laryngitis before and after treatment: preliminary results. Braz J Otorhinolaryngol. 2007 Mar-Apr;73(2):156-60. doi: 10.1016/s1808-8694(15)31060-0.'}, {'pmid': '7556968', 'type': 'BACKGROUND', 'citation': 'Sarosiek J, McCallum RW. Do salivary organic components play a protective role in health and disease of the esophageal mucosa? Digestion. 1995;56 Suppl 1:32-7. doi: 10.1159/000201299.'}, {'pmid': '8053431', 'type': 'BACKGROUND', 'citation': 'Rourk RM, Namiot Z, Edmunds MC, Sarosiek J, Yu Z, McCallum RW. Diminished luminal release of esophageal epidermal growth factor in patients with reflux esophagitis. Am J Gastroenterol. 1994 Aug;89(8):1177-84.'}]}, 'descriptionModule': {'briefSummary': '* Saliva plays an important role in the homeostasis of the digestive tract mucosa.\n* Salivary organic components, such as the Epidermal Growth Factor(EGF) have been found in defficient concentrations in patients with gastroesophageal reflux disease (GERD) and reflux related laryngitis (LPR).\n* 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\n* Eperdermal growth factor receptor (EGFR) overexpression has been linked to hyperproliferative diseases.\n* It is unknown if the inflammatory process in GERD is realated to difficiencies in EGFR expression.\n* 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', 'detailedDescription': '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. Fishers´s exact test and multivariance ANOVA tests were used with significance level established at 95%.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults with reflux laryngitis diagnosed by clinical symptoms (Reflux Symptom -Index \\>13) and videolaryngoscopic signs (Reflux Finding Score \\>7)\n* A positive 24-hour doube probe esophageal ph monitoring test\n\nExclusion Criteria:\n\n* Other known causes of chronic laryngitis or inflammatory conditions of the pharynx, larynx and upper digestive tract.\n* Current or past history of Head and Neck or digestive tract tumors.'}, 'identificationModule': {'nctId': 'NCT01806220', 'acronym': 'EGFR', 'briefTitle': 'Laryngeal and Esophageal EGF-r Expression in Patients With Reflux Laryngitis', 'organization': {'class': 'OTHER', 'fullName': 'Faculdade de Ciências Médicas da Santa Casa de São Paulo'}, 'officialTitle': 'Laryngeal and Esophageal EGF-r Expression in Patients With Reflux Laryngitis', 'orgStudyIdInfo': {'id': 'fcmscsp180/06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'biopsy of retrocrycoid laryngeal mucosa', 'description': 'During upper digestive endoscopy a biopsy specimen of the retrocrycoid laryngeal mucosa was obtained with a forceps introduced by the working channel of the scope.\n\nIntervention: biopsy of retrocrycoid laryngeal mucosa', 'interventionNames': ['Procedure: Biopsy of the retrocrycoid laryngeal mucosa']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'biopsy of distal esophagus mucosa', 'description': 'during upper digestive endoscopy a biopsy specimen of the distal esophageal mucosa was obtained\n\nIntervention:biopsy of distal esophagus mucosa', 'interventionNames': ['Procedure: Biopsy of the distal esophageal mucosa']}], 'interventions': [{'name': 'Biopsy of the retrocrycoid laryngeal mucosa', 'type': 'PROCEDURE', 'description': 'Biopsies of the retrocrycoid laryngeal mucosa were performeed under sedation using a forceps introduced by the working channel of the endoscope', 'armGroupLabels': ['biopsy of retrocrycoid laryngeal mucosa']}, {'name': 'Biopsy of the distal esophageal mucosa', 'type': 'PROCEDURE', 'description': 'Biopsies were performeed under sedation using a forceps introduced by the working channel of the endoscope during upper digestive endoscopy', 'armGroupLabels': ['biopsy of distal esophagus mucosa']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01222-010', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Santa Casa School of Medicine and Hospitals of São Paulo Brazil', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'CLAUDIA A ECKLEY, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SANTA CASA SCHOOL OF MEDICINE AND HOSPITALS OF SÃO PAULO BRAZIL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Faculdade de Ciências Médicas da Santa Casa de São Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor Otolaryngology Department', 'investigatorFullName': 'CLAUDIA ALESSANDRA ECKLEY', 'investigatorAffiliation': 'Faculdade de Ciências Médicas da Santa Casa de São Paulo'}}}}