Human Papillomatosis Genotyping of Children in Thailand

Completed

• Conditions: Human Papilloma Virus; Recurrent Laryngeal Papillomatosis

• Registration Number: NCT01304966
• Lead Sponsor: Queen Sirikit National Institute of Child Health

Brief Summary

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.

Detailed Description

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.

Objective:

* 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 Timeline

• Study First Submitted: 2011-02-25
• Study First Submitted QC: 2011-02-25
• Study First Posted: 2011-02-28
• Study Start: 2011-03
• Primary Completion: 2012-09
• Study Completion: 2012-12
• Results First Submitted: 2013-04-13
• Status Verified: 2013-10
• Results First Submitted QC: 2014-01-01
• Last Update Submitted: 2014-01-01
• Results First Posted: 2014-02-17
• Last Update Posted: 2014-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Patients have active laryngeal papillomatosis .
• Patients have developed this infection before the age of 18 years old.

Exclusion Criteria

• Children whose families do not sign an informed consent to enter into study.
• Children whose families anticipate discontinuing care at a participating institution during the study period.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Human Papillomavirus Genotypes	12 months	Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy

Secondary Outcome Measures

Name	Time	Method
Cotreta-Derkay Score	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 : Clinical score: 1. Voice: Normal - 0, Abnormal - 1, Aphonia - 2; 2. Stridor: Absent - 0, Present on activity - 1, Present at rest - 2; 3. Respiratory distress - None - 0, Mild - 1, Moderate - 2, Severe - 3, Extreme - 4.; Anatomical score: For each site - 0 = none, 1=surface lesion, 2= raised lesion, 3=bulky lesion.; Total score = Anatomical score + Total clinical score

Trial Locations

Locations (2)

Queen Sirikit National Institute of Child Health; 🇹🇭 Bangkok, Thailand

Department of Otorhinolaryngology: Queen Sirikit National of Child Health; 🇹🇭 Bangkok, Thailand