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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000858
Receipt No. R000001022
Scientific Title Genetic analysis of gastric lesion of MALT lymphoma
Date of disclosure of the study information 2007/11/01
Last modified on 2014/05/09

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Basic information
Public title Genetic analysis of gastric lesion of MALT lymphoma
Acronym Genetic analysis of gastric MALT lymphoma
Scientific Title Genetic analysis of gastric lesion of MALT lymphoma
Scientific Title:Acronym Genetic analysis of gastric MALT lymphoma
Region
Japan

Condition
Condition gastric MALT lymphoma
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To elusidate the biological mechanism and to develop a novel therapeutic strategy of gastric MALT lymphoma, we analyze genetic aberration of gastric MALT lymphoma.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes API2-MALT1 fusion gene
Aberrant DNA methylation
Aberrant expression of microRNA
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 Patients who were diagnosed with gastric MALT lymphoma by upper gastrointestinal endoscope
Key exclusion criteria Patients who are taking medicine for anticoagulant therapy
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidekazu Suzuki
Organization Keio University, School of Medicine
Division name Division of Gastroenterology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Keio University, School of Medicine
Division name Division of Gastroenterology
Zip code
Address
TEL 03-5363-3914
Homepage URL
Email

Sponsor
Institute Keio University, School of Medicine
Institute
Department

Funding Source
Organization Keio University
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
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
2007 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3509063/
Number of participants that the trial has enrolled
Results
microRNAs (miRNAs) are small non-coding RNAs that can function as endogenous silencers of target genes and play critical roles in human malignancies. To investigate the molecular pathogenesis of gastric mucosa-associated lymphoid tissue (MALT) lymphoma, the miRNA expression profile was analyzed. miRNA microarray analysis with tissue specimens from gastric MALT lymphomas and surrounding non-tumor mucosae revealed that a hematopoietic-specific miRNA miR-142 and an oncogenic miRNA miR-155 were overexpressed in MALT lymphoma lesions. The expression levels of miR-142-5p and miR-155 were significantly increased in MALT lymphomas which do not respond to Helicobacter pylori (H. pylori) eradication. The expression levels of miR-142-5p and miR-155 were associated with the clinical courses of gastric MALT lymphoma cases. Overexpression of miR-142-5p and miR-155 was also observed in Helicobacter heilmannii-infected C57BL/6 mice, an animal model of gastric MALT lymphoma. In addition, miR-142-5p and miR-155 suppress the proapoptotic gene TP53INP1 as their target. The results of this study indicate that overexpression of miR-142-5p and miR-155 plays a critical role in the pathogenesis of gastric MALT lymphoma. These miRNAs might have potential application as therapeutic targets and novel biomarkers for gastric MALT lymphoma.
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 Completed
Date of protocol fixation
2007 Year 09 Month 27 Day
Date of IRB
Anticipated trial start date
2007 Year 09 Month 01 Day
Last follow-up date
2012 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information n.p.

Management information
Registered date
2007 Year 10 Month 18 Day
Last modified on
2014 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001022

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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