UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044017 |
|---|---|
| Receipt number | R000050266 |
| Scientific Title | Impact of gut environment on the development of intestinal graft-versus-host disease during allogeneic hematopoietic stem cell transplantation |
| Date of disclosure of the study information | 2021/04/30 |
| Last modified on | 2021/11/24 21:22:47 |
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Basic information
Public title
Impact of gut environment on the development of intestinal graft-versus-host disease, a complication of hematopoietic stem cell transplantation
Acronym
Impact of gut environment on the development of intestinal graft-versus-host disease, a complication of hematopoietic stem cell transplantation
Scientific Title
Impact of gut environment on the development of intestinal graft-versus-host disease during allogeneic hematopoietic stem cell transplantation
Scientific Title:Acronym
Impact of gut environment on the development of intestinal graft-versus-host disease during allogeneic hematopoietic stem cell transplantation
Region
| Japan |
Condition
Condition
Hematological disorders eligible for allogeneic hematopoietic stem cell transplantation
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the gut environment involved in the pathogenesis of intestinal GVHD and to identify predictive markers and novel targets that contribute to the modulation of intestinal GVHD pathogenesis.
Basic objectives2
Others
Basic objectives -Others
Unraveling disease pathophysiology
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Gut environment involved in the onset of intestinal GVHD
Key secondary outcomes
The gut environment involved in the severity of intestinal GVHD
Intestinal environment involved in prognosis after transplantation
Similarity of gut environment between patients and donors and its relation to pathogenesis and prognosis of GVHD
Alterations in the gut environment during the process from autologous to donor hematopoiesis
Comparison of the gut environment in intestinal GVHD and inflammatory bowel disease
Relationship between endoscopic findings and severity of intestinal GVHD
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
Patients and their donors undergoing allogeneic hematopoietic stem cell transplantation at Yamagata University Hospital
Patients and their donors who have been fully informed of the purpose of the study in the consent document approved by the Ethical Review Committee and have given their free written consent.
Patients and their donors who are 20 years of age or older at the time of consent.
Key exclusion criteria
Patients with synchronous multiple cancers.
Patients with a history of bowel resection.
Patients who are unable to collect stool. However, if only the donor is unable to collect stool and the patient is able to collect stool, the patient will not be excluded.
Other patients deemed inappropriate by the investigators.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Yoshiyuki |
| Middle name | |
| Last name | Ueno |
Organization
Faculty of Medicine, Yamagata University
Division name
Department of Gastroenterology
Zip code
990-9585
Address
2-2-2 Iida-Nishi, Yamagata, Japan
TEL
0236285309
y-ueno@med.id.yamagata-u.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Sasaki |
Organization
Faculty of Medicine, Yamagata University
Division name
Department of Gastroenterology
Zip code
9909585
Address
2-2-2 Iida-Nishi, Yamagata, Japan
TEL
0236285309
Homepage URL
y-sasaki@med.id.yamagata-u.ac.jp
Sponsor or person
Institute
Faculty of Medicine, Yamagata University
Institute
Department
Personal name
Funding Source
Organization
None
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
Research Support Division, Administrative Department, Yamagata University Iida Campus
Address
2-2-2 Iida-Nishi, Yamagata, Japan
Tel
023-628-5047
ikekenkyu@jm.kj.yamagata-u.ac.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
山形大学医学部附属病院/Yamagata University Hospital
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 04 | Month | 30 | 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
| 2021 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
The patients and their donors aged 20 years or older who will undergo allogeneic hematopoietic stem cell transplantation at Yamagata University Hospital between May 1, 2021 and March 31, 2026. Any indication that led to the transplant is eligible. The clinical, hematological, and endoscopic findings, gut microbiota, and gut metabolome will be compared between the GVHD group and the non-GVHD group before transplantation and throughout the period of donor-derived hematopoietic engraftment. We will also compare the gut environments of donors and recipients.
Management information
Registered date
| 2021 | Year | 04 | Month | 23 | Day |
Last modified on
| 2021 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050266
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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