Human Papillomatosis Genotyping of Children in Thailand

Human Papillomatosis Genotyping and Severity in Patients With Recurrent Respiratory Papillomatosis 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 Overview

• Status: Completed
• Conditions: Human Papilloma Virus; Recurrent Laryngeal Papillomatosis
• Intervention / Treatment: Procedure: biopsy

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 Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand, 10400
    • Queen Sirikit National Institute of Child Health
  • Bangkok, Thailand, 10400
    • Department of Otorhinolaryngology: Queen Sirikit National of Child Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Target enrollment will be all children who are diagnosed with RRP.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Human Papillomavirus Genotypes	Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cotreta-Derkay Score	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	12 months

Collaborators and Investigators

• Sponsor: Queen Sirikit National Institute of Child Health
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Pavinee Intakorn, MD, Queen Sirikit National Institute of Child Health; Principal Investigator: Pavinee Intakorn, MD, Queen Sirikit National of Child Health

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): September 1, 2012
• Study Completion (Actual): December 1, 2012

Study Registration Dates

• First Submitted: February 25, 2011
• First Submitted That Met QC Criteria: February 25, 2011
• First Posted (Estimate): February 28, 2011

Study Record Updates

• Last Update Posted (Estimate): February 17, 2014
• Last Update Submitted That Met QC Criteria: January 1, 2014
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: HPV; RRP
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Papilloma
• Other Study ID Numbers: qnischent01