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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011395
Receipt No. R000013342
Scientific Title A research about clinical impacts of chromosomal abnormalities in patients of gastrointestinal malignant lymphoma
Date of disclosure of the study information 2013/08/07
Last modified on 2016/01/18

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Basic information
Public title A research about clinical impacts of chromosomal abnormalities in patients of gastrointestinal malignant lymphoma
Acronym A research about clinical impacts of chromosomal abnormalities in patients of gastrointestinal malignant lymphoma
Scientific Title A research about clinical impacts of chromosomal abnormalities in patients of gastrointestinal malignant lymphoma
Scientific Title:Acronym A research about clinical impacts of chromosomal abnormalities in patients of gastrointestinal malignant lymphoma
Region
Japan

Condition
Condition Gastrointestinal malignant lymphoma
Classification by specialty
Medicine in general Gastroenterology Hematology and clinical oncology
Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the association between chromosomal abnormalities and clinicopathological features in gastrointestinal patients
Basic objectives2 Others
Basic objectives -Others Significance of chromosomal abnormalities
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival rate
Key secondary outcomes Progression free survival rate

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients in whom gastrointestinal malignant lymphoma was diagnosed at the department of medical and clinical science, Kyushu university, from 1970 to 2015.
Key exclusion criteria Patients without necessary clinical informations, or those without samples of lymphoma, or patients who reject this research
Target sample size 450

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takanari Kitazono
Organization Kyushu univercity hospital
Division name Department of medicine and clinical science
Zip code
Address 3-1-1, Maidashi, Higashi-ku,Fukuoka-shi,Fukuoka.
TEL 092-642-5261
Email kitazono@intmed2.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Koji Ikegami
Organization Kyushu univercity hospital
Division name Department of medicine and clinical science
Zip code
Address Department of medicine and clinical science
TEL +81(0)92-642-5261
Homepage URL
Email kikegami@intmed2.med.kyushu-u.ac.jp

Sponsor
Institute Department of medicine and clinical science, Kyushu univercity
Institute
Department

Funding Source
Organization MHLW(Japan)
Organization
Division
Category of Funding Organization
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 九州大学病院(福岡県)

Other administrative information
Date of disclosure of the study information
2013 Year 08 Month 07 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The incidence of translocation involving IGH gene in intestinal diffuse large B-cell lymphoma is high.The translocation may be predictive of a favorable clinical course. Histopathology in press
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
2012 Year 08 Month 09 Day
Date of IRB
Anticipated trial start date
2012 Year 08 Month 09 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
2014 Year 12 Month 31 Day
Date trial data considered complete
2014 Year 12 Month 31 Day
Date analysis concluded
2015 Year 03 Month 06 Day

Other
Other related information The result of this research is partially published at JDDW2012 and UEGW2012.

Management information
Registered date
2013 Year 08 Month 06 Day
Last modified on
2016 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013342

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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