UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059954 |
|---|---|
| Receipt number | R000068552 |
| Scientific Title | Study on the Diagnostic Utility of the CD56/CD3 Ratio in Gastrointestinal Mucosal Lymphocytes for GVHD after Hematopoietic Stem Cell Transplantation |
| Date of disclosure of the study information | 2025/12/03 |
| Last modified on | 2025/12/03 10:39:56 |
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Basic information
Public title
Study on the Diagnostic Utility of the CD56/CD3 Ratio in Gastrointestinal Mucosal Lymphocytes for GVHD after Hematopoietic Stem Cell Transplantation
Acronym
GRAIL (GVHD Recognition by Analysis of Intraepithelial Lymphocytes using the CD56/CD3 Ratio)
Scientific Title
Study on the Diagnostic Utility of the CD56/CD3 Ratio in Gastrointestinal Mucosal Lymphocytes for GVHD after Hematopoietic Stem Cell Transplantation
Scientific Title:Acronym
GRAIL (GVHD Recognition by Analysis of Intraepithelial Lymphocytes using the CD56/CD3 Ratio)
Region
| Japan |
Condition
Condition
Patients after hematopoietic stem cell transplantation
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether the CD56/CD3 ratio of gastrointestinal mucosal lymphocytes is useful for diagnosing gastrointestinal GVHD in patients after hematopoietic stem cell transplantation
Basic objectives2
Others
Basic objectives -Others
A prospective observational study evaluating the concordance between the mucosal CD56/CD3 ratio assessed by flow cytometry and histopathology-based diagnosis of gastrointestinal GVHD
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Biopsy specimens will be prospectively obtained from the gastrointestinal mucosa of patients after hematopoietic stem cell transplantation, and the CD56/CD3 ratio will be evaluated by flow cytometric analysis. The diagnostic concordance with graft-versus-host disease will be assessed by comparing the flow cytometry findings with histopathological results.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who have undergone hematopoietic stem cell transplantation and are scheduled to undergo gastrointestinal endoscopy with biopsy
Key exclusion criteria
Women who are pregnant or may be pregnant
Target sample size
100
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
0862357219
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
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku
TEL
0862357219
Homepage URL
iwamuromasaya@yahoo.co.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Masaya Iwamuro
Funding Source
Organization
Okayama University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University IRB
Address
2-5-1 Shikata-cho, Kita-ku
Tel
0862357219
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
None Selected
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 03 | 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
| 2025 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2025 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will include patients who have undergone hematopoietic stem cell transplantation and are scheduled to undergo gastrointestinal endoscopy. During endoscopy, one additional biopsy specimen will be obtained from the gastrointestinal mucosa beyond routine clinical sampling. Flow cytometric analysis will be performed to evaluate the CD56/CD3 ratio, and its concordance with the histopathological diagnosis of gastrointestinal GVHD will be assessed.
Management information
Registered date
| 2025 | Year | 12 | Month | 03 | Day |
Last modified on
| 2025 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068552
