Human Papillomatosis Genotyping and Severity in Patients With Recurrent Respiratory Papillomatosis of Children in Thailand
| Registry | NCT01304966 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 15 (Actual) |
| Sponsor | Queen Sirikit National Institute of Child Health (Other gov); collaborators: Merck Sharp & Dohme LLC |
| Conditions | Recurrent Laryngeal Papillomatosis, Human Papilloma Virus |
| Interventions | biopsy (Procedure) |
| Dates | start 2011-03-01, primary completion 2012-09-01, completion 2012-12-01, first posted 2011-02-28, last updated 2014-02-17 |
| Locations | 2 sites in Thailand |
Related Papers Related Patents Related Grants Related Experts
All trials for Recurrent Laryngeal Papillomatosis All trials for Human Papilloma Virus All trials of biopsy
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.
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
Sex: All, ages: any to 18 Years
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.
| Milestone | Children With Recurrent Respiratory Papillomatosis |
|---|---|
| Started | 15 |
| Completed | 15 |
| Not completed | 0 |
Time frame: 12 months
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Children With Recurrent Respiratory Papillomatosis | 0 | 0 | 0 |
Limitations and caveats: The number of patients participating in this study was low , so additional studies should be conducted to make the research more effective.
| Facility | City | Country | Status |
|---|---|---|---|
| Department of Otorhinolaryngology: Queen Sirikit National of Child Health | Bangkok, Bangkok | Thailand | |
| Queen Sirikit National Institute of Child Health | Bangkok, Bangkok | Thailand |