Clinical trial NCT01304966: Human Papillomatosis Genotyping of Children in Thailand
Official title: Human Papillomatosis Genotyping and Severity in Patients With Recurrent Respiratory Papillomatosis of Children in Thailand
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Laryngeal Papillomatosis
Human Papilloma Virus
Keywords: RRP
HPV
Lead sponsor: Queen Sirikit National Institute of Child Health
Sponsor class: OTHER_GOV
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2011-02-28
Enrollment: 15
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Target enrollment will be all children who are diagnosed with RRP.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Human Papillomavirus Genotypes
timeFrame: 12 months
Secondary outcomes:
measure: Cotreta-Derkay Score
timeFrame: 12 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Otorhinolaryngology: Queen Sirikit National of Child Health
city: Bangkok
country: Thailand
facility: Queen Sirikit National Institute of Child Health
Study officials:
affiliation: Queen Sirikit National Institute of Child Health
name: Pavinee Intakorn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Queen Sirikit National of Child Health
name: Pavinee Intakorn, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.1002/lary.5541040503.
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. doi: 10.1288/00005537-199201000-00002.
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. doi: 10.1007/s100240010105.