UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019667 |
|---|---|
| Receipt number | R000022369 |
| Scientific Title | Methotrexate intravitreal injection to intraocular malignant lymphoma patients |
| Date of disclosure of the study information | 2015/11/06 |
| Last modified on | 2015/11/24 13:32:51 |
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Basic information
Public title
Methotrexate intravitreal injection to intraocular malignant lymphoma patients
Acronym
Methotrexate intravitreal injection to intraocular malignant lymphoma patients
Scientific Title
Methotrexate intravitreal injection to intraocular malignant lymphoma patients
Scientific Title:Acronym
Methotrexate intravitreal injection to intraocular malignant lymphoma patients
Region
| Japan |
Condition
Condition
intraocular malignant lymphoma
Classification by specialty
| Ophthalmology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the validity of the intravitrealinjection of methotrexate to a malignant lymphoma patienats.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The degree of improvement of the clinical presentation.
Key secondary outcomes
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
Injection of 400 ug of methotrexate into a vitreous cabity twice a week for 1 month as introduction therapy, once a week for 1 month as reinforcement therapy, and once a month for 1 year as maintenance therapy.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) patients that has a malignant lymphoma , have choroid infiltrate and vitreal opacity and isn't effectual for radiotherapy.
2) more than 20 years old, less than 90 years old in the time of the agreement
3) male and female
4) informed consented patients
5) hospitalizing and foreignness
Key exclusion criteria
1) the patient an overlap of other retina vitreous diseases fixes or doubts
2) the patient who can't have a doubtful point in a fixation check and get consent between the medical specialist
3) the patient who participated in a clinical clinical trial within 3 months of sample extraction
4) the patient who allowed a study responsibility doctor to be unsuitable
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Kimura |
Organization
Yamaguchi university hospital
Division name
ophthalmology
Zip code
Address
Minami Kogushi1-1-1, Yamaguhi, Ube
TEL
0836-22-2278
k.kimura@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Kimura |
Organization
Yamaguchi university hospital
Division name
ophthalmology
Zip code
Address
Minami Kogushi1-1-1, Yamaguhi, Ube
TEL
0836-22-2278
Homepage URL
k.kimura@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi university hospital
Institute
Department
Personal name
Funding Source
Organization
Yamaguchi university hospital ophthalmology
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2006 | Year | 12 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 12 | Month | 08 | 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
| 2015 | Year | 11 | Month | 06 | Day |
Last modified on
| 2015 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022369
