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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032121
Receipt No. R000036332
Scientific Title Study of evaluating therapeutic efficacy of intravitreal methotrexate in patients with primary intraocular lymphoma
Date of disclosure of the study information 2018/04/10
Last modified on 2019/10/11

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Basic information
Public title Study of evaluating therapeutic efficacy of intravitreal methotrexate in patients with primary intraocular lymphoma
Acronym Evaluation of therapeutic efficacy of intravitreal MTX in patients with PIOL
Scientific Title Study of evaluating therapeutic efficacy of intravitreal methotrexate in patients with primary intraocular lymphoma
Scientific Title:Acronym Evaluation of therapeutic efficacy of intravitreal MTX in patients with PIOL
Region
Japan

Condition
Condition primary intraocular lymphoma
Classification by specialty
Ophthalmology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We evaluate clinical safety of intravitreal methotrexate in patients with primary intraocular lymphoma.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Systemic and ophthalmological adverse effects and frequency
Key secondary outcomes 1. frequency of intraocular recurrences
2. recurrence-free survival
3. response rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients receive 0.1ml of MTX (diluted to a concentration of 400ug/0.1ml using saline) by intravitreal injection.
MTX is administrated twice a week for 4 weeks, after that once a week for 4 weeks, and injected at every 4weeks x 12 times.
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
80 years-old >
Gender Male and Female
Key inclusion criteria patients with primary intraocular lymphoma
Key exclusion criteria 1. performance status 4
2. patients who participated in other clinical trials within three months
3. patients with severe allergy to MTX
4. patients who desire for childbearing
5. patients with severe dementia or psychiatric disorder
6. Patients suggested as ineligible by their attending physician

Target sample size 16

Research contact person
Name of lead principal investigator
1st name Kazuhisa
Middle name
Last name Sugiyama
Organization Kanazawa University Hospital
Division name Department of opthalmology and visual science
Zip code 9208641
Address 13-1, Takara machi, Kanazawa, Ishikawa, JAPAN
TEL 076-265-2403
Email yuko-t@med.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name Yuko
Middle name
Last name Takemoto
Organization Kanazawa University Hospital
Division name Department of opthalmology and visual science
Zip code 9208641
Address 13-1, Takara machi, Kanazawa, Ishikawa, JAPAN
TEL 076-265-2403
Homepage URL
Email yuko-t@med.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University Hospital
Institute
Department

Funding Source
Organization Kanazawa University Hospital
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 Kanazawa University Hospital
Address 13-1, Takara-machi, Kanazawa, Ishikawa
Tel 076-265-2049
Email crc.irb-knz@esct.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
2018 Year 04 Month 10 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
2018 Year 03 Month 28 Day
Date of IRB
Anticipated trial start date
2018 Year 03 Month 28 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2020 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2018 Year 04 Month 05 Day
Last modified on
2019 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036332

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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