UMIN-CTR Clinical Trial

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

Gastrointestinal malignant lymphoma

Classification by specialty

Medicine in general	Gastroenterology	Hematology and clinical oncology
Adult

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

06

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

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