NCT01304966

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

February 17, 2014

Completed
Last Updated

February 17, 2014

Status Verified

October 1, 2013

Enrollment Period

1.5 years

First QC Date

February 25, 2011

Results QC Date

April 13, 2013

Last Update Submit

January 1, 2014

Conditions

Recurrent Laryngeal PapillomatosisHuman Papilloma Virus

Keywords

RRPHPV

Outcome Measures

Primary Outcomes (1)

  • Human Papillomavirus Genotypes

    Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy

    12 months

Secondary Outcomes (1)

  • Cotreta-Derkay Score

    12 months

Interventions

biopsyPROCEDURE

excisional biopsy

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

Target enrollment will be all children who are diagnosed with RRP.

You may qualify if:

  • Patients have active laryngeal papillomatosis .
  • Patients have developed this infection before the age of 18 years old.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Otorhinolaryngology: Queen Sirikit National of Child Health

Bangkok, Bangkok, 10400, Thailand

Location

Queen Sirikit National Institute of Child Health

Bangkok, Bangkok, 10400, Thailand

Location

Related Publications (4)

  • 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: 7488368BACKGROUND

  • 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: 8189980BACKGROUND

  • 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: 1309932BACKGROUND

  • 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: 11200493BACKGROUND

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.

MeSH Terms

Conditions

Laryngeal papillomatosis

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

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.

Results Point of Contact

Title
Dr.Pavinee Intakorn
Organization
Queen Sirikit Nation Institute of Thailand
pintakorn@yahoo.com
06623548333

Study Officials

  • Pavinee Intakorn, MD

    Queen Sirikit National Institute of Child Health

    PRINCIPAL INVESTIGATOR

  • Pavinee Intakorn, MD

    Queen Sirikit National of Child Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
department of otorhinolarngology

Study Record Dates

First Submitted

February 25, 2011

First Posted

February 28, 2011

Study Start

March 1, 2011

Primary Completion

September 1, 2012

Study Completion

December 1, 2012

Last Updated

February 17, 2014

Results First Posted

February 17, 2014

Record last verified: 2013-10

Locations

TH(2)