Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-03-01 @ 6:02 AM
Study NCT ID:
NCT02592902
Status:
COMPLETED
Last Update Posted:
2019-02-20
First Post:
2015-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recurrent Respiratory Papillomatosis and Extraesophageal Reflux
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C535297', 'term': 'Recurrent respiratory papillomatosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-18', 'studyFirstSubmitDate': '2015-10-29', 'studyFirstSubmitQcDate': '2015-10-29', 'lastUpdatePostDateStruct': {'date': '2019-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of EER (percentage)', 'timeFrame': '36 months', 'description': 'The occurrence of extra oesophageal reflux will be assessed in both study groups.'}], 'secondaryOutcomes': [{'measure': 'Presence of pepsin', 'timeFrame': '36 months', 'description': 'The presence of pepsin (yes-no) will be assessed in both study groups.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['recurrent respiratory papillomatosis', 'extra oesophageal reflux', 'laryngeal cyst', 'phonosurgery', 'oesophageal impedance'], 'conditions': ['Recurrent Respiratory Papillomatosis', 'Extra Oesophageal Reflux', 'Laryngeal Cyst']}, 'referencesModule': {'references': [{'pmid': '18496162', 'type': 'BACKGROUND', 'citation': 'Derkay CS, Wiatrak B. Recurrent respiratory papillomatosis: a review. Laryngoscope. 2008 Jul;118(7):1236-47. doi: 10.1097/MLG.0b013e31816a7135.'}, {'pmid': '19005325', 'type': 'BACKGROUND', 'citation': 'Gallagher TQ, Derkay CS. Recurrent respiratory papillomatosis: update 2008. Curr Opin Otolaryngol Head Neck Surg. 2008 Dec;16(6):536-42. doi: 10.1097/MOO.0b013e328316930e.'}, {'pmid': '19284366', 'type': 'BACKGROUND', 'citation': 'Gallagher TQ, Derkay CS. Pharmacotherapy of recurrent respiratory papillomatosis: an expert opinion. Expert Opin Pharmacother. 2009 Mar;10(4):645-55. doi: 10.1517/14656560902793530.'}, {'pmid': '18046565', 'type': 'BACKGROUND', 'citation': 'Goon P, Sonnex C, Jani P, Stanley M, Sudhoff H. Recurrent respiratory papillomatosis: an overview of current thinking and treatment. Eur Arch Otorhinolaryngol. 2008 Feb;265(2):147-51. doi: 10.1007/s00405-007-0546-z. Epub 2007 Nov 29.'}, {'pmid': '1309932', 'type': 'BACKGROUND', 'citation': 'Kashima HK, Shah F, Lyles A, Glackin R, Muhammad N, Turner L, Van Zandt S, Whitt S, Shah K. A comparison of risk factors in juvenile-onset and adult-onset recurrent respiratory papillomatosis. Laryngoscope. 1992 Jan;102(1):9-13. doi: 10.1288/00005537-199201000-00002.'}, {'pmid': '16847177', 'type': 'BACKGROUND', 'citation': 'Maloney EM, Unger ER, Tucker RA, Swan D, Karem K, Todd NW, Reeves WC. Longitudinal measures of human papillomavirus 6 and 11 viral loads and antibody response in children with recurrent respiratory papillomatosis. Arch Otolaryngol Head Neck Surg. 2006 Jul;132(7):711-5. doi: 10.1001/archotol.132.7.711.'}, {'pmid': '19050916', 'type': 'BACKGROUND', 'citation': 'Mammas IN, Sourvinos G, Spandidos DA. Human papilloma virus (HPV) infection in children and adolescents. Eur J Pediatr. 2009 Mar;168(3):267-73. doi: 10.1007/s00431-008-0882-z. Epub 2008 Dec 3.'}, {'pmid': '15850681', 'type': 'BACKGROUND', 'citation': 'McKenna M, Brodsky L. Extraesophageal acid reflux and recurrent respiratory papilloma in children. Int J Pediatr Otorhinolaryngol. 2005 May;69(5):597-605. doi: 10.1016/j.ijporl.2004.11.021.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study was to determine, whether patients with recurrent respiratory papillomatosis (RRP) suffer from extra oesophageal reflux more often than patients with laryngeal cyst (control group).', 'detailedDescription': 'Recurrent respiratory papillomatosis (RRP) is a chronic viral disease, which affects children and adults as well. It is characterised by grow of squamous cell tumours on mucosa of aerodigestive tract, with predilection for the larynx. The disease is caused by the human papillomavirus (HPV). However, in contrast to the low incidence of RRP, HPV prevalence is common. It is indicated that other factors may contribute to the pathogenesis of RRP. One such factor might be extraesophageal reflux (EER). We investigated whether patients with RRP suffer more often from EER.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 1-75 years\n* cooperating patients with laryngeal papillomatosis\n* patients tolerating impedance probe\n* signed informed consent, consent with the examinations\n* control group of patients with a cyst or vocal cord polyp (reflux finding score 0-2) and/or patients indicated to augmentation, medialization or lateralization of the vocal cords\n\nExclusion Criteria:\n\n* patients non-tolerating impedance catheter\n* patients who do not understand Czech language\n* patients who do not proclaim consent with enrolment into the study\n* patients who do not proclaim consent with the planned examinations\n* patients after surgical treatment of tumour of the swallowing or respiratory tract'}, 'identificationModule': {'nctId': 'NCT02592902', 'briefTitle': 'Recurrent Respiratory Papillomatosis and Extraesophageal Reflux', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Ostrava'}, 'officialTitle': 'Recurrent Respiratory Papillomatosis and Extraesophageal Reflux', 'orgStudyIdInfo': {'id': 'FNO-ENT-papilomatosis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Recurrent respiratory papillomatosis', 'description': 'Patients with recurrent respiratory papillomatosis (RRP) - surgical collection of histology specimen from the vocal cords and rear laryngeal commissure, performance of immunohistochemical analysis - proof of pepsin, HPV 6 and 11, herpes simplex virus (HSV) type 2, chlamydia trachomasis, and assessment of the dysplasia.', 'interventionNames': ['Procedure: Surgical collection of histology specimen', 'Procedure: Performance of immunohistochemical analysis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Laryngeal cyst - control group', 'description': 'Patients with laryngeal cyst - surgical collection of a histology specimen from the vocal cords and rear laryngeal commissure, performance of immunohistochemical analysis - proof of pepsin and HPV 6 and 11, herpes simplex virus (HSV) type 2 and chlamydia trachomasis.', 'interventionNames': ['Procedure: Surgical collection of histology specimen', 'Procedure: Performance of immunohistochemical analysis']}], 'interventions': [{'name': 'Surgical collection of histology specimen', 'type': 'PROCEDURE', 'description': 'Collection of a histology specimen from the vocal cords and rear laryngeal commissure', 'armGroupLabels': ['Laryngeal cyst - control group', 'Recurrent respiratory papillomatosis']}, {'name': 'Performance of immunohistochemical analysis', 'type': 'PROCEDURE', 'description': 'Immunohistochemical analysis - presence of pepsin, HPV 6 and 11, HSV 2 and chlamydia trachomasis', 'armGroupLabels': ['Laryngeal cyst - control group', 'Recurrent respiratory papillomatosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '708 52', 'city': 'Ostrava-Poruba', 'state': 'Czech Republic', 'country': 'Czechia', 'facility': 'University Hospital Ostrava'}], 'overallOfficials': [{'name': 'Martin Formanek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Ostrava'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Ostrava', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}