UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000006648
Receipt No. R000007776
Scientific Title Analysis of pathophysiology of intestinal graft-versus-host disease after HLA-haploidentical stem cell transplantation
Date of disclosure of the study information 2011/11/02
Last modified on 2011/11/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Analysis of pathophysiology of intestinal graft-versus-host disease after HLA-haploidentical stem cell transplantation
Acronym Intestinal GVHD after haplo-SCT
Scientific Title Analysis of pathophysiology of intestinal graft-versus-host disease after HLA-haploidentical stem cell transplantation
Scientific Title:Acronym Intestinal GVHD after haplo-SCT
Region
Japan

Condition
Condition Diseases that are treated with allogeneic stem cell transplantation, including acute myeloid leukemia, acute lymphoid leukemia, myelodysplastic syndrome, chronic myeloid leukemia, chronic lymphoid leukemia, myeloproliferative disorder, multiple myeloma, aplastic anemia, etc.
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Hematology and clinical oncology
Radiology Blood transfusion
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Pathophysiology of intestinal graft-versus-host disease following HLA-haploidentical stem cell transplantation
Basic objectives2 Others
Basic objectives -Others To identify factors to predict the occurrence of intestinal graft-versus-host disease, to clarify the mechanism of the disease, and to identify factors involved in the prognosis of the disease.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To identify parameter of intestinal GVHD following HLA-haploidentical stem cell transplantation
Key secondary outcomes 1. Impact of TMA and viral infections on intestinal symptoms after haploidentical stem cell transplantation.
2. To identify the best therapy of intestinal GVHD.
3. The usefulness of PET/CT scan for the diagnosis 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
15 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria Patients who undergo HLA-haploidentical stem cell transplantation.
Patients from whom we obtain written informed consent
Key exclusion criteria None
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyasu Ogawa
Organization Department of Internal Medicine, Hyogo College of Medicine
Division name Division of Hematology
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL 0798-45-6886
Email

Public contact
Name of contact person
1st name
Middle name
Last name Katsuji Kaida
Organization Department of Internal Medicine, Hyogo College of Medicine
Division name Division of Hematology
Zip code
Address 1-1, Mukogawa-cho, Nishinomiya, Hyogo
TEL 0798-45-6886
Homepage URL http://www.hosp.hyo-med.ac.jp/clinic/internal/hematology/index.html
Email kaidak@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

Funding Source
Organization A grant from the Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

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 兵庫医科大学 (兵庫県)

Other administrative information
Date of disclosure of the study information
2011 Year 11 Month 02 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
2011 Year 06 Month 12 Day
Date of IRB
Anticipated trial start date
2011 Year 11 Month 01 Day
Last follow-up date
2016 Year 06 Month 01 Day
Date of closure to data entry
2016 Year 12 Month 01 Day
Date trial data considered complete
2016 Year 12 Month 01 Day
Date analysis concluded
2017 Year 04 Month 01 Day

Other
Other related information Gastrointestinal and colon fiberscopic analyses are performed before transplantation, and 3 weeks and 6 weeks after transplantation. Using the biopsy specimens, immune cells infiltrating pathological intestinal lesions and their proliferation or apoptosis are analyzed. Viruses that cause intestinal symptoms are identified. PET/CT scans are performed before transplantation, and 3 weeks and 6 weeks after transplantation, and the usefulness of PET/CT findings for the diagnosis of intestinal GVHD is analyzed.
By these analyses, we establish the methods to enable a precise diagnosis of intestinal GVHD, and identify the prognostic factors of intestinal GVHD, and establish a novel therapy for intestinal GVHD after HLA-haploidentical stem cell transplantation.

Management information
Registered date
2011 Year 11 Month 01 Day
Last modified on
2011 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007776

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.