Human Papillomatosis Genotyping of Children in Thailand

The recruitment status of this study is unknown because the information has not been verified recently.

Verified April 2011 by Queen Sirikit National Institute of Child Health.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Merck

Information provided by:

Queen Sirikit National Institute of Child Health

ClinicalTrials.gov Identifier:

NCT01304966

First received: February 25, 2011

Last updated: April 18, 2011

Last verified: April 2011

History of Changes

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

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

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.

Estimated Enrollment:	14
Study Start Date:	March 2011
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Intervention Details:

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

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01304966

Contacts

Contact: Pavinee Intakorn, MD

6623548333 ext 2301

pintakorn@yahoo.com

Locations

Thailand
Department of Otorhinolaryngology: Queen Sirikit National of Child Health	Recruiting
Bangkok, Thailand, 10400
Contact: Pavinee Intakorn, MD 6623548333 ext 2301 pintakorn@yahoo.com
Principal Investigator: Pavinee Intakorn, MD
Queen Sirikit National Institute of Child Health	Recruiting
Bangkok, Thailand, 10400
Contact: Pavinee Intakorn, MD 6623548333 ext 2301 pintakorn@yahoo.com
Principal Investigator: Pavinee Intakorn, MD

Sponsors and Collaborators

Queen Sirikit National Institute of Child Health

Merck

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:

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

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

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.

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.

Responsible Party:	Queen Sirikit National Institute of Child Health, Department of Otorhinolaryngology :Queen Sirikit National Institute of Child Health
ClinicalTrials.gov Identifier:	NCT01304966 History of Changes
Other Study ID Numbers:	qnischent01
Study First Received:	February 25, 2011
Last Updated:	April 18, 2011
Health Authority:	Thailand: Ministry of Public Health

Keywords provided by Queen Sirikit National Institute of Child Health:

RRP
HPV

Additional relevant MeSH terms:

Papilloma
Laryngeal Neoplasms
Respiratory Tract Infections
Papillomavirus Infections
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
Infection
DNA Virus Infections
Virus Diseases
Tumor Virus Infections

ClinicalTrials.gov processed this record on June 17, 2013

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