UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter study on clinicopathological features, molecular genetic abnormalities, treatment and prognosis of gastrointestinal malignant lymphomas
Title of the study (Brief title)	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	Takanari Kitazono
Organization	Kyushu University
Division name	Department of Medicine and Clinical Science, Graduate School of Medical Sciences
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	Yuichi Matsuno
Organization	Kyushu University
Division name	Department of Medicine and Clinical Science, Graduate School of Medical Sciences
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 03 Month 29 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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