Human Papillomatosis Genotyping of Children in Thailand

NCT01304966 — Completed, 15 participants, Queen Sirikit National Institute of Child Health

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Human Papillomatosis Genotyping and Severity in Patients With Recurrent Respiratory Papillomatosis of Children in Thailand

RegistryNCT01304966
StatusCompleted
Study typeObservational
Enrollment15 (Actual)
SponsorQueen Sirikit National Institute of Child Health (Other gov); collaborators: Merck Sharp & Dohme LLC
ConditionsRecurrent Laryngeal Papillomatosis, Human Papilloma Virus
Interventionsbiopsy (Procedure)
Datesstart 2011-03-01, primary completion 2012-09-01, completion 2012-12-01, first posted 2011-02-28, last updated 2014-02-17
Locations2 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

-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.

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+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

+Arms and interventions

  • biopsy (Procedure): excisional biopsy

+Outcome measures

Primary outcomes

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

Secondary outcomes

  • 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

+Eligibility

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.

+Posted results

Participant flow

MilestoneChildren With Recurrent Respiratory Papillomatosis
Started15
Completed15
Not completed0

Outcome results

  • Human Papillomavirus Genotypes (Primary), Number, participants: Children With Recurrent Respiratory Papillomatosis 6
  • Cotreta-Derkay Score (Secondary), Mean, score: HPV 6 13.83 +/- 9.94; HPV 11 27.44 +/- 8.24 (p 0.013)

Adverse events

Time frame: 12 months

ArmDeathsSerious adverse eventsOther adverse events
Children With Recurrent Respiratory Papillomatosis000

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.

+Locations (2)

FacilityCityCountryStatus
Department of Otorhinolaryngology: Queen Sirikit National of Child HealthBangkok, BangkokThailand
Queen Sirikit National Institute of Child HealthBangkok, BangkokThailand

+Publications

  • 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. PMID 7488368
  • 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. PMID 8189980
  • 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. PMID 1309932
  • 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. PMID 11200493

+Investigators