UMIN-CTR Clinical Trial

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
Email	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
Email	yshdychr@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	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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000031548