Human Papillomatosis Genotyping of Children in Thailand
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Human Papillomatosis Genotyping and Severity in Patients With Recurrent Respiratory Papillomatosis of Children in Thailand|
- Human Papillomavirus Genotypes [ Time Frame: 12 months ] [ Designated as safety issue: No ]Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy
- Cotreta-Derkay Score [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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
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.
|Study Start Date:||March 2011|
|Study Completion Date:||December 2012|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: 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|