UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003968 |
|---|---|
| Receipt number | 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 23:21:07 |
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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
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
Sponsor or person
Institute
Department of Gastroenterology Osaka City University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004783
