UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027701
Receipt number 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 12:21:47

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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 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


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

Value
https://center6.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