UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017863 |
|---|---|
| Receipt number | R000020697 |
| Scientific Title | Treatment of Laryngeal Papillomatosis with Cidofovir |
| Date of disclosure of the study information | 2015/06/11 |
| Last modified on | 2023/12/16 09:29:39 |
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Basic information
Public title
Treatment of Laryngeal Papillomatosis with Cidofovir
Acronym
Treatment of Laryngeal Papillomatosis with Cidofovir
Scientific Title
Treatment of Laryngeal Papillomatosis with Cidofovir
Scientific Title:Acronym
Treatment of Laryngeal Papillomatosis with Cidofovir
Region
| Japan |
Condition
Condition
Laryngeal Papillomatosis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effectiveness of cidofovir to laryngeal papillomatosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
clinical findings of larynx
Key secondary outcomes
GRBAS score
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
cidofovir 7.5mg/ml local injection
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Pathologicaly diagnosed as larynx papilloma.
Written infomed consent to useage of cidofovir.
Key exclusion criteria
Refused to useage of cidofovir.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Mineta |
Organization
HAMAMATSU UNIVERSITY SCHOOL OF MEDICINE
Division name
Depertment of otorhinolaryngology
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL
053-435-2659
mineta@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kiyoshi |
| Middle name | |
| Last name | Misawa |
Organization
HAMAMATSU UNIVERSITY SCHOOL OF MEDICINE
Division name
Depertment of otorhinolaryngology
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
TEL
053-435-2659
Homepage URL
kiyoshim@hama-med.ac.jp
Sponsor or person
Institute
Depertment of otorhinolaryngology, HAMAMATSU UNIVERSITY SCHOOL OF MEDICINE
Institute
Department
Personal name
Funding Source
Organization
Depertment of otorhinolaryngology, HAMAMATSU UNIVERSITY SCHOOL OF MEDICINE
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
HAMAMATSU UNIVERSITY SCHOOL OF MEDICINE
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu city, Shizuoka, Japan
Tel
053-435-2111
yamoto@hama-med.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 11 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 11 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 10 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 10 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 10 | Day |
Date analysis concluded
| 2020 | Year | 06 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 10 | Day |
Last modified on
| 2023 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020697
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
