Human Papillomatosis Genotyping of Children in Thailand

Human Papilloma Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304966
• Other study ID #: qnischent01
• Status: Completed
• Phase: N/A
• First received: February 25, 2011
• Last updated: January 1, 2014
• Start date: March 2011
• Est. completion date: December 2012

Study information

• Verified date: October 2013
• Source: Queen Sirikit National Institute of Child Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Human Papilloma Virus
• Laryngeal Neoplasms
• Papilloma
• Recurrent Laryngeal Papillomatosis

Intervention

Procedure:
• biopsy
excisional biopsy

Locations

Country	Name	City	State
Thailand	Department of Otorhinolaryngology: Queen Sirikit National of Child Health	Bangkok
Thailand	Queen Sirikit National Institute of Child Health	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Queen Sirikit National Institute of Child Health	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Thailand, 

References & Publications (4)

Derkay CS. Task force on recurrent respiratory papillomas. A preliminary report. Arch Otolaryngol Head Neck Surg. 1995 Dec;121(12):1386-91. — View Citation

Doyle DJ, Gianoli GJ, Espinola T, Miller RH. Recurrent respiratory papillomatosis: juvenile versus adult forms. Laryngoscope. 1994 May;104(5 Pt 1):523-7. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Human Papillomavirus Genotypes	Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy	12 months	No
Secondary	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	No