UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040674 |
|---|---|
| Receipt number | R000046424 |
| Scientific Title | Analysis of lymphocyte composition of the gastrointestinal mucosa in patients after hematopoietic stem cell transplantation |
| Date of disclosure of the study information | 2020/06/08 |
| Last modified on | 2025/12/09 17:48:25 |
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Basic information
Public title
Analysis of lymphocyte composition of the gastrointestinal mucosa in patients after hematopoietic stem cell transplantation
Acronym
Gastrointestinal lymphocyte composition after hematopoietic stem cell transplantation
Scientific Title
Analysis of lymphocyte composition of the gastrointestinal mucosa in patients after hematopoietic stem cell transplantation
Scientific Title:Acronym
Gastrointestinal lymphocyte composition after hematopoietic stem cell transplantation
Region
| Japan |
Condition
Condition
Patients after hematopoietic stem cell transplantation
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze lymphocyte composition of the gastrointestinal mucosa in patients after hematopoietic stem cell transplantation
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To analyze lymphocyte composition of the gastrointestinal mucosa in patients after hematopoietic stem cell transplantation
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients after hematopoietic stem cell transplantation
Key exclusion criteria
Women who are pregnant or may be pregnant
Target sample size
50
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
0862357218
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 and Hepatology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862357218
Homepage URL
iwamuromasaya@yahoo.co.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Okayama University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Hospital
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
Tel
0862357218
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
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | Month | 08 | Day |
Related information
URL releasing protocol
https://ousar.lib.okayama-u.ac.jp/files/public/6/65740/20230821110142405934/77_4_347.pdf
Publication of results
Published
Result
URL related to results and publications
https://ousar.lib.okayama-u.ac.jp/files/public/6/65740/20230821110142405934/77_4_347.pdf
Number of participants that the trial has enrolled
35
Results
We assessed the feasibility of lymphocyte isolation and flow cytometry using a single gastrointestinal biopsy after stem cell transplantation. Among 51 specimens from 35 patients, isolation succeeded in 24 and failed in 27. Success rates differed by site: duodenum 88.9%, ileum 50.0%, large intestine 36.4%, stomach 34.8%. Tacrolimus use was more common in failures but not significant. Duodenum and ileum were the most suitable sites.
Results date posted
| 2025 | Year | 12 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients who have undergone hematopoietic stem cell transplantation
Participant flow
Endoscopic biopsies were obtained from patients who had undergone hematopoietic stem cell transplantation.
A total of 51 specimens were collected from 35 patients.
Specimens were classified into two groups based on the success of lymphocyte isolation:
- Group A: Successful lymphocyte isolation (n = 24)
- Group B: Incomplete isolation (n = 27)
Background characteristics and biopsy sites were compared between groups to identify factors associated with successful lymphocyte isolation.
Adverse events
None
Outcome measures
Primary outcome
Success or failure of lymphocyte isolation from a single endoscopic biopsy specimen.
Secondary outcomes
Success rates of lymphocyte isolation according to biopsy site.
Factors associated with successful lymphocyte isolation (e.g., biopsy location, medication use such as tacrolimus).
Identification of independent predictors through logistic regression analysis.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 06 | Month | 06 | Day |
Last modified on
| 2025 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046424
