Recurrent Laryngeal PapillomatosisNCT01304966
Human Papillomatosis Genotyping of Children in Thailand
An observational study of Recurrent Laryngeal Papillomatosis and Human Papilloma Virus, run by Queen Sirikit National Institute of Child Health at 2 sites in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Recurrent Laryngeal Papillomatosis, Human Papilloma Virus
- What is being tested?
- biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 2 sitesThailand
- Study dates
- Mar 2011to Dec 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Target enrollment will be all children who are diagnosed with RRP.
Who may be able to join
- Patients have active laryngeal papillomatosis .
- Patients have developed this infection before the age of 18 years old.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites
Department of Otorhinolaryngology: Queen Sirikit National of Child Health
Bangkok, Bangkok, 10400
Queen Sirikit National Institute of Child Health
Bangkok, Bangkok, 10400
About this study
Official title: Human Papillomatosis Genotyping and Severity in Patients With Recurrent Respiratory Papillomatosis of Children in Thailand
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.
Read the 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
- Being tested
- biopsy
- Keywords
- RRP, HPV
- Medical subject headings
- Laryngeal papillomatosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsyProcedure or surgery
excisional biopsy
What is being measured
The primary outcome is the main question the study is designed to answer.
Human Papillomavirus Genotypes
Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy
Measured: 12 months
Secondary outcomes (1)
Cotreta-Derkay Score
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:
- Voice: Normal - 0, Abnormal - 1, Aphonia - 2
- Stridor: Absent - 0, Present on activity - 1, Present at rest - 2
- 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2011 (estimated)
- Study startMar 2011
- Primary completionSep 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Recurrent Laryngeal PapillomatosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Sirikit National Institute of Child Health
- Sponsor type
- Other government
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Pavinee Intakorn, Queen Sirikit National Institute of Child Health
- Investigators
- Pavinee Intakorn, MD, Principal investigator, Queen Sirikit National Institute of Child HealthPavinee Intakorn, MD, Principal investigator, Queen Sirikit National of Child Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304966
- Sponsor's protocol ID
- qnischent01
- Status last verified
- Oct 2013
- First submitted
- 25 Feb 2011
- Last updated
- 17 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 7488368Doyle 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.
PubMed 8189980Kashima 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.
PubMed 1309932Rabah 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.
PubMed 11200493
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Papillomatosis Genotyping and Severity in Patients With Recurrent Respiratory Papillomatosis of Children in Thailand
- ClinicalTrials.gov ID
- NCT01304966
- Acronym / sponsor ID
- qnischent01
- Keywords
- RRP, HPV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Queen Sirikit National Institute of Child HealthOther government
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Mar 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Feb 2011 (estimated)
- Results
- Posted 17 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Target enrollment will be all children who are diagnosed with RRP.
Key inclusion criteria (2 listed)
- Patients have active laryngeal papillomatosis .
- Patients have developed this infection before the age of 18 years old.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biopsyexcisional biopsy | Procedure or surgery | – |
Primary outcome
Human Papillomavirus Genotypes
Time frame: 12 months
Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy
1 secondary outcome
Cotreta-Derkay Score
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 7488368Derkay 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.
- Background: PubMed 8189980Doyle 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.
- Background: PubMed 1309932Kashima 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.
- Background: PubMed 11200493Rabah 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pavinee Intakorn, MD principal investigator
Queen Sirikit National Institute of Child Health
Pavinee Intakorn, MD principal investigator
Queen Sirikit National of Child Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Recurrent Laryngeal Papillomatosis and Human Papilloma Virus, run by Queen Sirikit National Institute of Child Health at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Human Papillomavirus Genotypes (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01304966, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2014.