UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003929
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email shingo4@md.tsukuba.ac.jp

Sponsor
Institute Department of Neurosurgery, Faculty of Medicine, University of Tsukuba
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004721

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.