UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011395 |
|---|---|
| Receipt number | 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 20:38:38 |
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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
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
kikegami@intmed2.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of medicine and clinical science, Kyushu univercity
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013342
| 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 |
