UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intralesional Cidofovir application in recurrent laryngeal papillomatosis
Title of the study (Brief title)	Intralesional Cidofovir application in laryngeal papillomatosis
Region	Japan

Condition
Condition	laryngeal papillomatosis
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to determine the efficacy of intralesional injection of cidofovir in improving resolution of recurrent respiratory papillomatosis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	to determine of frequency of relapses, and size.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	recurrent laryngeal papillma
Key exclusion criteria	non recurrent laryngeal papillma
Target sample size	1

Research contact person
Name of lead principal investigator	Eiji Yumoto
Organization	Kumamoto university
Division name	Otolaryngology Head & Neck Suregry
Address	1-1-1 Honjyo, Kumamoto
TEL	096-373-7076
Email	jibika-ikyoku@kuh.kumamoto-u.ac.jp

Public contact
Name of contact person	Tetsuji Sanuki
Organization	Kumamoto university
Division name	Otolaryngology Head & Neck Suregry
Address	1-1-1 Honjyo, Kumamoto
TEL	096-373-7076
Homepage URL
Email	otostl0319@kuh.kumamoto-u.ac.jp

Sponsor
Institute	Kumamoto university
Institute
Department

Funding Source
Organization	non
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	熊本大学病院

Other administrative information
Date of disclosure of the study information	2011 Year 10 Month 04 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2011 Year 09 Month 04 Day
Anticipated trial start date	2011 Year 10 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	observe drug response

Management information
Registered date	2011 Year 09 Month 27 Day
Last modified on	2017 Year 09 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007471