UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003929 |
|---|---|
| Receipt number | R000004721 |
| Scientific Title | Fundamentals of molecular targeted therapy for primary central nervous system lymphoma based on genomic alterations |
| Date of disclosure of the study information | 2010/07/21 |
| Last modified on | 2018/01/25 12:47:51 |
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Basic information
Public title
Fundamentals of molecular targeted therapy for primary central nervous system lymphoma based on genomic alterations
Acronym
Genomic alterations in CNS lymphoma
Scientific Title
Fundamentals of molecular targeted therapy for primary central nervous system lymphoma based on genomic alterations
Scientific Title:Acronym
Genomic alterations in CNS lymphoma
Region
| Japan |
Condition
Condition
primary central nervous system lymphoma
Classification by specialty
| Hematology and clinical oncology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Identify primary CNS lymphoma specific genomic alterations and construct fundamentals of molecular therapy based on the genomic alterations
Basic objectives2
Others
Basic objectives -Others
More than 50 cases of primary CNS lymphoma are collecetd for analysis of genomic alterations
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Identify primary CNS lymphoma specific genomic alterations.
Among them, find molecular target for development and progression of lymphoma
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Brain tumor tissue obtained at stereotactic and craniotomy operation by skillful neurosurgeons.
2. Two parts of brain tumor tissue, one is for pathological diagnosis (formalin fixation) and another is for genomic analysis (frozen tissue).
3. Pathological diagnosis is primary CNS lymphoma
Key exclusion criteria
nothing particular
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shingo Takano |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Neurosurgery
Zip code
Address
1-1-1 Tennoudai, Tsukuba city, Ibaraki 305-8575
TEL
029-853-3220
shingo4@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Takano |
Organization
Faculty of Medicine, University of Tsukuba
Division name
Department of Neurosurgery
Zip code
Address
1-1-1 Tennoudai, Tsukuba city, Ibaraki 305-8575
TEL
029(853)3220
Homepage URL
shingo4@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Faculty of Medicine, University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Department of Neurosurgery, Faculty of Medicine, University of Tsukuba
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Consortium for Brain Tumor Treatment
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
| 2010 | Year | 07 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 05 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collect more than 50 samplas of primary CNS lymphoma from 14 institutions during two years. Lymphoma samples are amalysed for genomic analysis using high density SNP array and any mutations of whole sequence using second generation sequencer. Among the genomic alterations found, identify the target gene for molecular therapy for primary CNS lymphoma.
Management information
Registered date
| 2010 | Year | 07 | Month | 20 | Day |
Last modified on
| 2018 | Year | 01 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004721
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
