Trial Outcomes & Findings for Human Papillomatosis Genotyping of Children in Thailand (NCT NCT01304966)

NCT ID: NCT01304966

Last Updated: 2014-02-17

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 15 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2014-02-17

Participant Flow

Date of the recruitment is APril 2011.Number participants staring is fifteen.

Participant milestones

Measure	Children With Recurrent Respiratory Papillomatosis Children hospitalized with recurrent respiratory papillomatosis who underwent biopsy
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Human Papillomatosis Genotyping of Children in Thailand

Baseline characteristics by cohort

Measure	Children With Recurrent Respiratory Papillomatosis n=15 Participants Children hospitalized with recurrent respiratory papillomatosis who underwent biopsy
Age, Continuous	2.67 years STANDARD_DEVIATION 0.049 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	15 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: 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.

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

Outcome measures

Measure	Children With Recurrent Respiratory Papillomatosis n=15 Participants Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy	HPV 11 Children with recurrent respiratory papillomatosis from HPV 11
Human Papillomavirus Genotypes HPV type 6	6 participants	—
Human Papillomavirus Genotypes HPV type 11	9 participants	—

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Children With Recurrent Respiratory Papillomatosis n=6 Participants Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy	HPV 11 n=9 Participants Children with recurrent respiratory papillomatosis from HPV 11
Cotreta-Derkay Score	13.83 score Standard Deviation 9.94	27.44 score Standard Deviation 8.24

Adverse Events

Children With Recurrent Respiratory Papillomatosis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Pavinee Intakorn

Queen Sirikit Nation Institute of Thailand

Phone: 06623548333

Email: pintakorn@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place