UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035064 |
|---|---|
| Receipt number | R000036839 |
| Scientific Title | Evaluation of esophagogastroduodenoscopy and colonoscopy with biopsy in the diagnosis of acute intestinal graft-versus-host disease. |
| Date of disclosure of the study information | 2018/11/29 |
| Last modified on | 2020/11/06 19:20:04 |
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Basic information
Public title
Evaluation of esophagogastroduodenoscopy and colonoscopy with biopsy in the diagnosis of acute intestinal graft-versus-host disease.
Acronym
Evaluation of EGD and CS in the diagnosis of GVHD
Scientific Title
Evaluation of esophagogastroduodenoscopy and colonoscopy with biopsy in the diagnosis of acute intestinal graft-versus-host disease.
Scientific Title:Acronym
Evaluation of EGD and CS in the diagnosis of GVHD
Region
| Japan |
Condition
Condition
patients who underwent allo-SCT
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary aim of our study was to evaluate the yield of EGD versus CS.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
evaluate the yield of EGD versus CS
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with acute GVHD from May 2008 to September 2017 by histopathological diagnosis after allogeneic hematopoietic stem cell transplant gastrointestinal endoscopy or colonoscopy
Key exclusion criteria
Patient after colon surgery
Patient disqualified patient
Target sample size
133
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuusaku Sugihara |
Organization
Okayama university hospital
Division name
Department of internal medicine
Zip code
Address
Okayama city kitaku shikata 2-5-1
TEL
086-235-7219
y.sugi117@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuusaku Sugihara |
Organization
Okayama university hospital
Division name
Department of internal medicine
Zip code
Address
Okayama city kitaku shikata 2-5-1
TEL
086-235-7219
Homepage URL
y.sugi117@gmail.com
Sponsor or person
Institute
Okayama university hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama university hospital
Organization
Division
Category of Funding Organization
Government offices of other countries
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
| 2018 | Year | 11 | Month | 29 | 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
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2020 | Year | 11 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2018 | Year | 11 | Month | 28 | Day |
Last modified on
| 2020 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036839
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
