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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000044017
Receipt No. 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 2021/04/23

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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
Email 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
Email y-sasaki@med.id.yamagata-u.ac.jp

Sponsor
Institute Faculty of Medicine, Yamagata University
Institute
Department

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
Email 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 Preinitiation
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 04 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050266

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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