UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007382 |
|---|---|
| Receipt number | R000008693 |
| Scientific Title | Topical mitomycin C therapy for ocular surface neoplasia |
| Date of disclosure of the study information | 2012/04/30 |
| Last modified on | 2021/05/10 09:36:56 |
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Basic information
Public title
Topical mitomycin C therapy for ocular surface neoplasia
Acronym
Topical mitomycin C therapy for ocular surface neoplasia
Scientific Title
Topical mitomycin C therapy for ocular surface neoplasia
Scientific Title:Acronym
Topical mitomycin C therapy for ocular surface neoplasia
Region
| Japan |
Condition
Condition
ocular surface neoplasia
Classification by specialty
| Ophthalmology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to evaluate the therapeutic efficacy and safety of topical mitomycin C for ocular surface neoplasia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
tumor size, location
Key secondary outcomes
symptoms, best-corrected visual acuity, intraocular pressure, findings of slit-lamp examination and indirect ophthalmoscopy
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
topical mitomycin C
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
patients with ocular surface neoplasia
Key exclusion criteria
patients with history of severe renal disorder, severe liver disorder or hypersensitivity to ingredients of this drug, patients with bone-marrow suppression, pregnant or lactating women
and women of child-bearing potential.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Nagai |
Organization
Kobe University Hospital
Division name
Department of Ophthalmology
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-6048
tnagai-1@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Nagai |
Organization
Kobe University Hospital
Division name
Department of Ophthalmology
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-6048
Homepage URL
tnagai-1@med.kobe-u.ac.jp
Sponsor or person
Institute
Department of Ophthalmology, Kobe University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Clinical and Translational Research Center, Kobe University Hospital
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe
Tel
078-382-6669
chiken@med.kobe-u.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
| 2012 | Year | 04 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 26 | Day |
Last modified on
| 2021 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008693
