UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006411 |
|---|---|
| Receipt number | R000007471 |
| Scientific Title | Intralesional Cidofovir application in recurrent laryngeal papillomatosis |
| Date of disclosure of the study information | 2011/10/04 |
| Last modified on | 2017/09/20 10:30:47 |
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Basic information
Public title
Intralesional Cidofovir application in recurrent laryngeal papillomatosis
Acronym
Intralesional Cidofovir application in laryngeal papillomatosis
Scientific Title
Intralesional Cidofovir application in recurrent laryngeal papillomatosis
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Eiji Yumoto |
Organization
Kumamoto university
Division name
Otolaryngology Head & Neck Suregry
Zip code
Address
1-1-1 Honjyo, Kumamoto
TEL
096-373-7076
jibika-ikyoku@kuh.kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tetsuji Sanuki |
Organization
Kumamoto university
Division name
Otolaryngology Head & Neck Suregry
Zip code
Address
1-1-1 Honjyo, Kumamoto
TEL
096-373-7076
Homepage URL
otostl0319@kuh.kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto university
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 04 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007471
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
