UMIN-CTR Clinical Trial

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

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

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Hyogo College of Medicine

Institute

Department

Personal name

Organization

A grant from the Ministry of Education, Culture, Sports, Science and Technology

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

Co-sponsor

None

Name of secondary funder(s)

None

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

兵庫医科大学 (兵庫県)

Date of disclosure of the study information

2011

Year

11

Month

02

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2011

Year

11

Month

01

Day

Last modified on

2011

Year

11

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007776