Human Papillomatosis Genotyping of Children in Thailand
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|ClinicalTrials.gov Identifier: NCT01304966|
Recruitment Status : Completed
First Posted : February 28, 2011
Results First Posted : February 17, 2014
Last Update Posted : February 17, 2014
|Condition or disease||Intervention/treatment|
|Recurrent Laryngeal Papillomatosis Human Papilloma Virus||Procedure: biopsy|
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.
- To identify the genotypes of HPV isolated from Thai RRP patients
- To compare staging and severity with HPV genotypes
- To correlate the following characteristics of the Thai RRP patients with the HPV genotypes
|Study Type :||Observational|
|Actual Enrollment :||15 participants|
|Official Title:||Human Papillomatosis Genotyping and Severity in Patients With Recurrent Respiratory Papillomatosis of Children in Thailand|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||December 2012|
- Procedure: biopsy
- Human Papillomavirus Genotypes [ Time Frame: 12 months ]Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy
- Cotreta-Derkay Score [ Time Frame: 12 months ]
We compared disease severity(Cotreta-Derkay score) between groups of children with two different HPV genotypes
Coltera and Derkay have evolved a staging system to stage recurrent papillomatous lesions involving the respiratory tract.
Coltera-Derkay method of staging :
- Voice: Normal - 0, Abnormal - 1, Aphonia - 2
- Stridor: Absent - 0, Present on activity - 1, Present at rest - 2
- Respiratory distress - None - 0, Mild - 1, Moderate - 2, Severe - 3, Extreme - 4.
For each site - 0 = none, 1=surface lesion, 2= raised lesion, 3=bulky lesion.
Total score = Anatomical score + Total clinical score
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01304966
|Department of Otorhinolaryngology: Queen Sirikit National of Child Health|
|Bangkok, Thailand, 10400|
|Queen Sirikit National Institute of Child Health|
|Bangkok, Thailand, 10400|
|Principal Investigator:||Pavinee Intakorn, MD||Queen Sirikit National Institute of Child Health|
|Principal Investigator:||Pavinee Intakorn, MD||Queen Sirikit National of Child Health|