UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032318 |
|---|---|
| Receipt number | R000036613 |
| Scientific Title | Real-time diagnosis of Gastrointestinal Graft-Versus-Host-Disease (GI-GVHD) using endoscopic microscopy |
| Date of disclosure of the study information | 2018/04/19 |
| Last modified on | 2018/12/12 09:23:27 |
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Basic information
Public title
Real-time diagnosis of Gastrointestinal Graft-Versus-Host-Disease (GI-GVHD)
using endoscopic microscopy
Acronym
Real-time diagnosis of Gastrointestinal Graft-Versus-Host-Disease (GI-GVHD)
using endoscopic microscopy
Scientific Title
Real-time diagnosis of Gastrointestinal Graft-Versus-Host-Disease (GI-GVHD)
using endoscopic microscopy
Scientific Title:Acronym
Real-time diagnosis of Gastrointestinal Graft-Versus-Host-Disease (GI-GVHD)
using endoscopic microscopy
Region
| Japan |
Condition
Condition
gastrointestinal GVHD(graft-versus-host disease)
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe cellular damage in patients with GI-GVHD using endocytoscopy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the correlations of numbers of goblet cells
and crypts with findings in endocytoscopic images and biopsy specimens
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients who undergo stem cell transplantation (SCT) in Hokkaido University Hospital are included.
1. the patients who undergo colonoscopy before SCT
2. the patients who are 20 years or older at the agreement acquisition
Key exclusion criteria
The patients who can not receive biopsy for background disease or use of antithrombotic drugs
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoko Ono |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
Address
Sapporo City, Kita-Ku, North15West7
TEL
+81-11-716-1161
kana.matsuda@true.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kana Matsuda |
Organization
Hokkaido University
Division name
Department of Gastroenterology and Hematology
Zip code
Address
Sapporo City, Kita-Ku, North15West7
TEL
011-706-5723
Homepage URL
kana.matsuda@true.ocn.ne.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
| 2018 | Year | 04 | Month | 19 | 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 | 06 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | 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
Prospective observational study
Management information
Registered date
| 2018 | Year | 04 | Month | 19 | Day |
Last modified on
| 2018 | Year | 12 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036613
