Human Papillomatosis Genotyping of Children in Thailand

NCT ID: NCT01304966

Last Updated: 2014-02-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2012-12-31

Brief Summary

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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

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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

Conditions

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Recurrent Laryngeal Papillomatosis Human Papilloma Virus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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biopsy

excisional biopsy

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Queen Sirikit National Institute of Child Health

OTHER_GOV

Sponsor Role lead

Responsible Party

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Pavinee Intakorn

department of otorhinolarngology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pavinee Intakorn, MD

Role: PRINCIPAL_INVESTIGATOR

Queen Sirikit National Institute of Child Health

Pavinee Intakorn, MD

Role: PRINCIPAL_INVESTIGATOR

Queen Sirikit National of Child Health

Locations

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Department of Otorhinolaryngology: Queen Sirikit National of Child Health

Bangkok, Bangkok, Thailand

Site Status

Queen Sirikit National Institute of Child Health

Bangkok, Bangkok, Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type BACKGROUND
PMID: 7488368 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8189980 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1309932 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11200493 (View on PubMed)

Other Identifiers

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qnischent01

Identifier Type: -

Identifier Source: org_study_id

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