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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biopsy | Procedure | excisional biopsy |
| Measure | Description | Time Frame |
|---|---|---|
| Human Papillomavirus Genotypes | Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
Anatomical score: For each site - 0 = none, 1=surface lesion, 2= raised lesion, 3=bulky lesion. Total score = Anatomical score + Total clinical score |
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Inclusion Criteria:
Exclusion Criteria:
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Target enrollment will be all children who are diagnosed with RRP.
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| Name | Affiliation | Role |
|---|---|---|
| Pavinee Intakorn, MD | Queen Sirikit National Institute of Child Health | Principal Investigator |
| Pavinee Intakorn, MD | Queen Sirikit National of Child Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Otorhinolaryngology: Queen Sirikit National of Child Health | Bangkok | Bangkok | 10400 | Thailand | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7488368 | Background | 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. | |
| 8189980 | Background | 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. |
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Date of the recruitment is APril 2011.Number participants staring is fifteen.
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| ID | Title | Description |
|---|---|---|
| FG000 | Children With Recurrent Respiratory Papillomatosis | Children hospitalized with recurrent respiratory papillomatosis who underwent biopsy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Children With Recurrent Respiratory Papillomatosis in Thailand
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| ID | Title | Description |
|---|---|---|
| BG000 | Children With Recurrent Respiratory Papillomatosis | Children hospitalized with recurrent respiratory papillomatosis who underwent biopsy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Human Papillomavirus Genotypes | Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy | We found positive HPV DNA in all children. HPV type 6 and HPV type 11 caused recurrent respiratory papillomatosis in 6 (40%) and 9(60%) of cases,respectively. | Posted | Number | participants | 12 months |
|
|
12 months
Since this is the observational study, therefore the study process did not pose any risk to the participants (population at risk = 0)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Children With Recurrent Respiratory Papillomatosis | Children hospitalized with recurrent respiratory papillomatosis who underwent biopsy |
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The number of patients participating in this study was low , so additional studies should be conducted to make the research more effective.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Pavinee Intakorn | Queen Sirikit Nation Institute of Thailand | 06623548333 | 2301 | pintakorn@yahoo.com |
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| ID | Term |
|---|---|
| C537876 | Laryngeal papillomatosis |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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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.
| 12 months |
| Queen Sirikit National Institute of Child Health |
| Bangkok |
| Bangkok |
| 10400 |
| Thailand |
| 1309932 | Background | 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. |
| 11200493 | Background | 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. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| Secondary | 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:
Anatomical score: For each site - 0 = none, 1=surface lesion, 2= raised lesion, 3=bulky lesion. Total score = Anatomical score + Total clinical score | Posted | Mean | Standard Deviation | score | 12 months |
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| 0 |
| 0 |
| 0 |
| 0 |
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| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |