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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027701
Receipt No. R000031547
Scientific Title Multicenter study on clinicopathological features, molecular genetic abnormalities, treatment and prognosis of gastrointestinal malignant lymphomas
Date of disclosure of the study information 2017/06/09
Last modified on 2017/06/09

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Basic information
Public title Multicenter study on clinicopathological features, molecular genetic abnormalities, treatment and prognosis of gastrointestinal malignant lymphomas
Acronym Multicenter study on clinicopathological features, molecular genetic abnormalities, treatment and prognosis of gastrointestinal malignant lymphomas
Scientific Title Multicenter study on clinicopathological features, molecular genetic abnormalities, treatment and prognosis of gastrointestinal malignant lymphomas
Scientific Title:Acronym Multicenter study on clinicopathological features, molecular genetic abnormalities, treatment and prognosis of gastrointestinal malignant lymphomas
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) Establish a registration system for patients with malignant lymphoma such as MALT lymphoma, diffuse large B cell lymphoma, follicular lymphoma and NK / T cell lymphoma, which are frequently found in the gastrointestinal tract, at Kyushu university hospital and collaborative research facilities.
2) Verify the data by retrospective examining the clinicopathological features, treatment and prognosis.
3) Evaluate the data by tracking the patient prospectively registered.
Basic objectives2 Others
Basic objectives -Others Correlation among clinicopathological features, molecular genetic abnormalities, treatment and prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between treatment and prognosis in gastrointestinal malignant lymphoma
Key secondary outcomes Correlation among clinicopathological features, chromosomal abnormalities, expression of miRNA or mRNA, prognosis, and therapeutic response of 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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with gastrointestinal malignant lymphoma diagnosed at Kyushu university hospital and collaborative research facilities from 1970 to 2023.
Key exclusion criteria Patients who reject this research.
Target sample size 700

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takanari Kitazono
Organization Kyushu University
Division name Department of Medicine and Clinical Science, Graduate School of Medical Sciences
Zip code
Address 3-1-1, Maidashi, Higashi-ku,Fukuoka-shi,Fukuoka.
TEL +81(0)92-642-5261
Email kitazono@intmed2.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuichi Matsuno
Organization Kyushu University
Division name Department of Medicine and Clinical Science, Graduate School of Medical Sciences
Zip code
Address 3-1-1, Maidashi, Higashi-ku,Fukuoka-shi,Fukuoka.
TEL +81(0)92-642-5261
Homepage URL
Email ymatsuno@intmed2.med.kyushu-u.ac.jp

Sponsor
Institute Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
Institute
Department

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
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
2017 Year 06 Month 09 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 03 Month 29 Day
Date of IRB
Anticipated trial start date
2017 Year 03 Month 29 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) Evaluate the data by tracking the patient prospectively registered and clarify the correlation among therapy, prognosis and etc. of gastrointestinal malignant lymphoma.

Management information
Registered date
2017 Year 06 Month 09 Day
Last modified on
2017 Year 06 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031547

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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