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Completed

NCT Number: NCT01304966

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.

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biopsy

Procedure

excisional biopsy

Primary outcomes

  1. Human Papillomavirus Genotypes

    Time frame: 12 months

    Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy

Secondary outcomes

  1. 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 :

    Clinical score:

    • 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.

    Anatomical score:

    For each site - 0 = none, 1=surface lesion, 2= raised lesion, 3=bulky lesion.

    Total score = Anatomical score + Total clinical score

Sponsors and collaborators

Lead sponsor

Queen Sirikit National Institute of Child Health

Other Gov

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Human Papillomatosis Genotyping and Severity in Patients With Recurrent Respiratory Papillomatosis of Children in Thailand

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 28, 2011
Registry last updated
Feb 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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