Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2025-12-27 @ 5:21 PM
Study NCT ID:
NCT01304966
Status:
COMPLETED
Last Update Posted:
2014-02-17
First Post:
2011-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Human Papillomatosis Genotyping of Children in Thailand
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C537876', 'term': 'Laryngeal papillomatosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pintakorn@yahoo.com', 'phone': '06623548333', 'title': 'Dr.Pavinee Intakorn', 'phoneExt': '2301', 'organization': 'Queen Sirikit Nation Institute of Thailand'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The number of patients participating in this study was low , so additional studies should be conducted to make the research more effective.'}}, 'adverseEventsModule': {'timeFrame': '12 months', 'description': 'Since this is the observational study, therefore the study process did not pose any risk to the participants (population at risk = 0)', 'eventGroups': [{'id': 'EG000', 'title': 'Children With Recurrent Respiratory Papillomatosis', 'description': 'Children hospitalized with recurrent respiratory papillomatosis who underwent biopsy', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Human Papillomavirus Genotypes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Children With Recurrent Respiratory Papillomatosis', 'description': 'Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy'}], 'classes': [{'title': 'HPV type 6', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'HPV type 11', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 months', 'description': 'Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'We found positive HPV DNA in all children. HPV type 6 and HPV type 11 caused recurrent respiratory papillomatosis in 6 (40%) and 9(60%) of cases,respectively.'}, {'type': 'SECONDARY', 'title': 'Cotreta-Derkay Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'HPV 6', 'description': 'Children with recurrent respiratory papillomatosis from HPV 6'}, {'id': 'OG001', 'title': 'HPV 11', 'description': 'Children with recurrent respiratory papillomatosis from HPV 11'}], 'classes': [{'categories': [{'measurements': [{'value': '13.83', 'spread': '9.94', 'groupId': 'OG000'}, {'value': '27.44', 'spread': '8.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '12 months', 'description': 'We compared disease severity(Cotreta-Derkay score) between groups of children with two different HPV genotypes\n\nColtera and Derkay have evolved a staging system to stage recurrent papillomatous lesions involving the respiratory tract.\n\nColtera-Derkay method of staging :\n\nClinical score:\n\n1. Voice: Normal - 0, Abnormal - 1, Aphonia - 2\n2. Stridor: Absent - 0, Present on activity - 1, Present at rest - 2\n3. Respiratory distress - None - 0, Mild - 1, Moderate - 2, Severe - 3, Extreme - 4.\n\nAnatomical score:\n\nFor each site - 0 = none, 1=surface lesion, 2= raised lesion, 3=bulky lesion.\n\nTotal score = Anatomical score + Total clinical score', 'unitOfMeasure': 'score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Children With Recurrent Respiratory Papillomatosis', 'description': 'Children hospitalized with recurrent respiratory papillomatosis who underwent biopsy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Date of the recruitment is APril 2011.Number participants staring is fifteen.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Children With Recurrent Respiratory Papillomatosis', 'description': 'Children hospitalized with recurrent respiratory papillomatosis who underwent biopsy'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '2.67', 'spread': '0.049', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Children With Recurrent Respiratory Papillomatosis in Thailand'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Papillomatous tissue samples taken from endoscopic biopsies will be collected by the ENT specialists.Samples collected from the subjects will be analyzed for HPV genotype at the Unit of virology and molecular, Department of pathology, Faculty of medicine Ramathibodi hospital.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-01', 'studyFirstSubmitDate': '2011-02-25', 'resultsFirstSubmitDate': '2013-04-13', 'studyFirstSubmitQcDate': '2011-02-25', 'lastUpdatePostDateStruct': {'date': '2014-02-17', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-01-01', 'studyFirstPostDateStruct': {'date': '2011-02-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Human Papillomavirus Genotypes', 'timeFrame': '12 months', 'description': 'Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy'}], 'secondaryOutcomes': [{'measure': 'Cotreta-Derkay Score', 'timeFrame': '12 months', 'description': 'We compared disease severity(Cotreta-Derkay score) between groups of children with two different HPV genotypes\n\nColtera and Derkay have evolved a staging system to stage recurrent papillomatous lesions involving the respiratory tract.\n\nColtera-Derkay method of staging :\n\nClinical score:\n\n1. Voice: Normal - 0, Abnormal - 1, Aphonia - 2\n2. Stridor: Absent - 0, Present on activity - 1, Present at rest - 2\n3. Respiratory distress - None - 0, Mild - 1, Moderate - 2, Severe - 3, Extreme - 4.\n\nAnatomical score:\n\nFor each site - 0 = none, 1=surface lesion, 2= raised lesion, 3=bulky lesion.\n\nTotal score = Anatomical score + Total clinical score'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['RRP', 'HPV'], 'conditions': ['Recurrent Laryngeal Papillomatosis', 'Human Papilloma Virus']}, 'referencesModule': {'references': [{'pmid': '7488368', 'type': 'BACKGROUND', 'citation': 'Derkay CS. Task force on recurrent respiratory papillomas. A preliminary report. Arch Otolaryngol Head Neck Surg. 1995 Dec;121(12):1386-91. doi: 10.1001/archotol.1995.01890120044008.'}, {'pmid': '8189980', 'type': 'BACKGROUND', 'citation': 'Doyle DJ, Gianoli GJ, Espinola T, Miller RH. Recurrent respiratory papillomatosis: juvenile versus adult forms. Laryngoscope. 1994 May;104(5 Pt 1):523-7. doi: 10.1002/lary.5541040503.'}, {'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': '11200493', 'type': 'BACKGROUND', 'citation': 'Rabah R, Lancaster WD, Thomas R, Gregoire L. Human papillomavirus-11-associated recurrent respiratory papillomatosis is more aggressive than human papillomavirus-6-associated disease. Pediatr Dev Pathol. 2001 Jan-Feb;4(1):68-72. doi: 10.1007/s100240010105.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the present study was to identify risk factors for more severe juvenile Recurrent Respiratory Papillomatosis (RRP) through prospective evaluation of a pediatric population in Thailand by the employing a protocol that includes staging of disease severity using above mentioned staging system at the time of each endoscopic debridement, as well as human papilloma virus (HPV) genotyping.', 'detailedDescription': 'Recurrent respiratory papillomatosis is caused by human papilloma virus and is the most common benign laryngeal neoplasm in children. Although RRP is rarely fatal, the disease requires prolonged, extensive medical and surgical treatment, and causes physical and emotional suffering in affected children and their families. Although recurrent respiratory papillomatosis is a relatively unusual problem, it accounts for significant health are expenditures.The goal of management of RRP is control of the disease, preservation of the voice and prevention of major complication .The purpose of study will identify risk factors for more severe juvenile RRP through prospective evaluation of a pediatric population in Thailand by the employing a protocol that includes staging of disease severity , as well as HPV genotyping.\n\nObjective:\n\n* To identify the genotypes of HPV isolated from Thai RRP patients\n* To compare staging and severity with HPV genotypes\n* To correlate the following characteristics of the Thai RRP patients with the HPV genotypes'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Target enrollment will be all children who are diagnosed with RRP.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients have active laryngeal papillomatosis .\n* Patients have developed this infection before the age of 18 years old.\n\nExclusion Criteria:\n\n* Children whose families do not sign an informed consent to enter into study.\n* Children whose families anticipate discontinuing care at a participating institution during the study period.'}, 'identificationModule': {'nctId': 'NCT01304966', 'briefTitle': 'Human Papillomatosis Genotyping of Children in Thailand', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Queen Sirikit National Institute of Child Health'}, 'officialTitle': 'Human Papillomatosis Genotyping and Severity in Patients With Recurrent Respiratory Papillomatosis of Children in Thailand', 'orgStudyIdInfo': {'id': 'qnischent01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'biopsy', 'type': 'PROCEDURE', 'description': 'excisional biopsy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Department of Otorhinolaryngology: Queen Sirikit National of Child Health', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'zip': '10400', 'city': 'Bangkok', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Queen Sirikit National Institute of Child Health', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Pavinee Intakorn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queen Sirikit National Institute of Child Health'}, {'name': 'Pavinee Intakorn, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Queen Sirikit National of Child Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Sirikit National Institute of Child Health', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'department of otorhinolarngology', 'investigatorFullName': 'Pavinee Intakorn', 'investigatorAffiliation': 'Queen Sirikit National Institute of Child Health'}}}}