UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040674
Receipt number R000046424
Scientific Title Analysis of lymphocyte composition of the gastrointestinal mucosa in patients after hematopoietic stem cell transplantation
Date of disclosure of the study information 2020/06/08
Last modified on 2020/06/06 12:54:22

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Basic information

Public title

Analysis of lymphocyte composition of the gastrointestinal mucosa in patients after hematopoietic stem cell transplantation

Acronym

Gastrointestinal lymphocyte composition after hematopoietic stem cell transplantation

Scientific Title

Analysis of lymphocyte composition of the gastrointestinal mucosa in patients after hematopoietic stem cell transplantation

Scientific Title:Acronym

Gastrointestinal lymphocyte composition after hematopoietic stem cell transplantation

Region

Japan


Condition

Condition

Patients after hematopoietic stem cell transplantation

Classification by specialty

Hepato-biliary-pancreatic medicine Hematology and clinical oncology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To analyze lymphocyte composition of the gastrointestinal mucosa in patients after hematopoietic stem cell transplantation

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

To analyze lymphocyte composition of the gastrointestinal mucosa in patients after hematopoietic stem cell transplantation

Key secondary outcomes



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

99 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients after hematopoietic stem cell transplantation

Key exclusion criteria

Women who are pregnant or may be pregnant

Target sample size

50


Research contact person

Name of lead principal investigator

1st name Masaya
Middle name
Last name Iwamuro

Organization

Okayama University Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code

700-8558

Address

2-5-1 Shikata-cho, Kita-ku, Okayama

TEL

0862357218

Email

iwamuromasaya@yahoo.co.jp


Public contact

Name of contact person

1st name Masaya
Middle name
Last name Iwamuro

Organization

Okayama University Hospital

Division name

Department of Gastroenterology and Hepatology

Zip code

700-8558

Address

2-5-1 Shikata-cho, Kita-ku, Okayama

TEL

0862357218

Homepage URL


Email

iwamuromasaya@yahoo.co.jp


Sponsor or person

Institute

Okayama University

Institute

Department

Personal name



Funding Source

Organization

Okayama University

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

Okayama University Hospital

Address

2-5-1 Shikata-cho, Kita-ku, Okayama

Tel

0862357218

Email

iwamuromasaya@yahoo.co.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

2020 Year 06 Month 08 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

Enrolling by invitation

Date of protocol fixation

2020 Year 06 Month 05 Day

Date of IRB

2020 Year 06 Month 05 Day

Anticipated trial start date

2020 Year 06 Month 08 Day

Last follow-up date

2021 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

None


Management information

Registered date

2020 Year 06 Month 06 Day

Last modified on

2020 Year 06 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046424


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name