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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003968
Receipt No. R000004783
Scientific Title The examination of efficacy of small bowel exploration in gastrointestinal graft-versus-host-disease after hematopoietic stem cell transplantation
Date of disclosure of the study information 2010/07/31
Last modified on 2010/08/15

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Basic information
Public title The examination of efficacy of small bowel exploration in gastrointestinal graft-versus-host-disease after hematopoietic stem cell transplantation
Acronym The examination of efficacy of small bowel exploration in GI-GVHD after SCT
Scientific Title The examination of efficacy of small bowel exploration in gastrointestinal graft-versus-host-disease after hematopoietic stem cell transplantation
Scientific Title:Acronym The examination of efficacy of small bowel exploration in GI-GVHD after SCT
Region
Japan

Condition
Condition Gastrointestinal Graft-versus-Host Disease
Classification by specialty
Gastroenterology Hematology and clinical oncology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The examination of efficacy of small bowel exploration in gastrointestinal graft-versus-host-disease after hematopoietic stem cell transplantation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The histologic GVHD positive rate of the small bowel in case acute GVHD is suspected clinically after hematopoietic stem cell transplantation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Case acute GVHD is suspected clinically within 100 days after hematopoietic stem cell transplantation
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Case acute GVHD is suspected clinically within 100 days after hematopoietic stem cell transplantation.
Case to severity classification stage 3 of gastrointestinalGVHD.
Key exclusion criteria Case of the umbilical cord blood transplant.
Case having a serious complication.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuo Arakawa
Organization Department of Osaka City University Graduate School of Medicine
Division name Gastroenterology
Zip code
Address 1-5-7 Asahimachi abenoku osakacity
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Gastroenterology
Division name Endoscope part
Zip code
Address
TEL 0666453811
Homepage URL
Email

Sponsor
Institute Department of Gastroenterology Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Gastroenterology Osaka City University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
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
2010 Year 07 Month 31 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
2010 Year 07 Month 30 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 07 Month 29 Day
Last modified on
2010 Year 08 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004783

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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