UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027752 |
|---|---|
| Receipt number | R000031548 |
| Scientific Title | Study on clinical significance of molecular biological abnormality in gastrointestinal malignant lymphoma |
| Date of disclosure of the study information | 2017/06/15 |
| Last modified on | 2021/01/11 09:52:30 |
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Basic information
Public title
Study on clinical significance of molecular biological abnormality in gastrointestinal malignant lymphoma
Acronym
Study on clinical significance of molecular biological abnormality in gastrointestinal malignant lymphoma
Scientific Title
Study on clinical significance of molecular biological abnormality in gastrointestinal malignant lymphoma
Scientific Title:Acronym
Study on clinical significance of molecular biological abnormality in 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
1) Investigate chromosomal abnormalities and gene expression profiles of malignant lymphoma with high frequency in the digestive tract, such as MALT lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, NK / T cell lymphoma at Kyushu university hospital.
2) Analyze comprehensively the relationship between these abnormalities and clinicopathological features.
Basic objectives2
Others
Basic objectives -Others
Correlation among clinicopathological features, molecular abnormalities and treatment and prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between molecular abnormality and prognosis in gastrointestinal malignant lymphoma
Key secondary outcomes
Correlations among clinicopathological features, molecular abnormalities, treatment and prognosis in gastrointestinal malignant lymphoma
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
Prospective study
(1) Patients diagnosed with gastrointestinal malignant lymphoma at Kyushu University Hospital.
(2) Patients who fully understand this research plan and are able to consent by the principal and the substitute
(3) Patients who are aged 20 years or older at the time of acquisition
Retrospective study
(1) Patients diagnosed with gastrointestinal malignant lymphoma at Kyushu University Hospital from January 1, 1970 to March 31, 2017.
Key exclusion criteria
Patients who reject this research
In prospective study, fresh frozen specimens are not collected if the patient has bleeding tendency.
Target sample size
540
Research contact person
Name of lead principal investigator
| 1st name | Takanari |
| Middle name | |
| Last name | Kitazono |
Organization
Kyushu University
Division name
Department of Medicine and Clinical Science, Graduate School of Medical Sciences
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka.
TEL
+81(0)92-642-5261
kitazono@intmed2.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuichirou |
| Middle name | |
| Last name | Yoshida |
Organization
Kyushu University
Division name
Department of Medicine and Clinical Science, Graduate School of Medical Sciences
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka.
TEL
+81(0)92-642-5261
Homepage URL
yshdychr@med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu university certitied institutional review board for clinical traials
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka.
Tel
+81(0)92-642-5775
bynintei@jimu.kyushu-u.ac.jp
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
| 2017 | Year | 06 | Month | 15 | 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
| 2017 | Year | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(1) In prospective study, written informed consent is obtained after giving an explanation to the patient. In the retrospective study, information on this study is made public on the website after permission of the study.
(2) Register the relevant patient as a subject and obtain the clinical information from the medical record at the time of registration.
(3) Gene expression and mutation analysis are performed and evaluated as follows.
1. We search chromosomal abnormalities by fluorescent in situ hybridization (FISH) method using a DNA probe specific for each gene region, using paraffin-embedded tissue of gastrointestinal malignant lymphoma obtained during endoscopic examination or surgery for diagnosis or treatment.
2. We perform comprehensive gene expression profile analysis by microarray system and nCounter Analysis System (R) using RNA and DNA that extracted from paraffin-embedded tissue or fresh frozen biopsy specimens additionally done for research purposes.
3. By the above, the molecules which increase or decrease the expression specifically are identified, immunohistochemical staining are carried out and examined in further detail.
Management information
Registered date
| 2017 | Year | 06 | Month | 14 | Day |
Last modified on
| 2021 | Year | 01 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031548
