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Human Papillomatosis Genotyping of Children in Thailand

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01304966
First Posted: February 28, 2011
Last Update Posted: February 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Pavinee Intakorn, Queen Sirikit National Institute of Child Health
  Purpose
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.

Condition Intervention
Recurrent Laryngeal Papillomatosis Human Papilloma Virus Procedure: biopsy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Human Papillomatosis Genotyping and Severity in Patients With Recurrent Respiratory Papillomatosis of Children in Thailand

Resource links provided by NLM:


Further study details as provided by Pavinee Intakorn, Queen Sirikit National Institute of Child Health:

Primary Outcome Measures:
  • Human Papillomavirus Genotypes [ Time Frame: 12 months ]
    Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy


Secondary Outcome Measures:
  • Cotreta-Derkay Score [ Time Frame: 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



Biospecimen Retention:   Samples With DNA
Papillomatous tissue samples taken from endoscopic biopsies will be collected by the ENT specialists.Samples collected from the subjects will be analyzed for HPV genotype at the Unit of virology and molecular, Department of pathology, Faculty of medicine Ramathibodi hospital.

Enrollment: 15
Study Start Date: March 2011
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: biopsy
    excisional 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
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Target enrollment will be all children who are diagnosed with RRP.
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01304966


Locations
Thailand
Department of Otorhinolaryngology: Queen Sirikit National of Child Health
Bangkok, Thailand, 10400
Queen Sirikit National Institute of Child Health
Bangkok, Thailand, 10400
Sponsors and Collaborators
Queen Sirikit National Institute of Child Health
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Pavinee Intakorn, MD Queen Sirikit National Institute of Child Health
Principal Investigator: Pavinee Intakorn, MD Queen Sirikit National of Child Health
  More Information

Publications:
Responsible Party: Pavinee Intakorn, department of otorhinolarngology, Queen Sirikit National Institute of Child Health
ClinicalTrials.gov Identifier: NCT01304966     History of Changes
Other Study ID Numbers: qnischent01
First Submitted: February 25, 2011
First Posted: February 28, 2011
Results First Submitted: April 13, 2013
Results First Posted: February 17, 2014
Last Update Posted: February 17, 2014
Last Verified: October 2013

Keywords provided by Pavinee Intakorn, Queen Sirikit National Institute of Child Health:
RRP
HPV

Additional relevant MeSH terms:
Papilloma
Laryngeal Neoplasms
Neoplasms, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Laryngeal Diseases
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Otorhinolaryngologic Diseases