Human Papilloma Virus, Recurrent Laryngeal Papillomatosis
Conditions
Keywords
RRP, HPV
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
Interventions
PROCEDUREbiopsy
excisional biopsy
Sponsors
Merck Sharp & Dohme LLC
Queen Sirikit National Institute of Child Health
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Human Papillomavirus Genotypes | 12 months | Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cotreta-Derkay Score | 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: 1. Voice: Normal - 0, Abnormal - 1, Aphonia - 2 2. Stridor: Absent - 0, Present on activity - 1, Present at rest - 2 3. 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 |
Countries
Thailand
Participant flow
Recruitment details
Date of the recruitment is APril 2011.Number participants staring is fifteen.
Participants by arm
| Arm | Count |
|---|---|
| Children With Recurrent Respiratory Papillomatosis Children hospitalized with recurrent respiratory papillomatosis who underwent biopsy | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | Children With Recurrent Respiratory Papillomatosis |
|---|---|
| Age, Continuous | 2.67 years STANDARD_DEVIATION 0.049 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 15 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Human Papillomavirus Genotypes
Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy
Time frame: 12 months
Population: We found positive HPV DNA in all children. HPV type 6 and HPV type 11 caused recurrent respiratory papillomatosis in 6 (40%) and 9(60%) of cases,respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Children With Recurrent Respiratory Papillomatosis | Human Papillomavirus Genotypes | HPV type 6 | 6 participants |
| Children With Recurrent Respiratory Papillomatosis | Human Papillomavirus Genotypes | HPV type 11 | 9 participants |
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: 1. Voice: Normal - 0, Abnormal - 1, Aphonia - 2 2. Stridor: Absent - 0, Present on activity - 1, Present at rest - 2 3. 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
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Children With Recurrent Respiratory Papillomatosis | Cotreta-Derkay Score | 13.83 score | Standard Deviation 9.94 |
| HPV 11 | Cotreta-Derkay Score | 27.44 score | Standard Deviation 8.24 |
p-value: 0.013t-test, 1 sided