UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007793 |
|---|---|
| Receipt number | R000009183 |
| Scientific Title | A prospective observational study for a validation of National Institutes of Health criteria for late-acute and chronic GVHD (KSGCT1201 / NIH-GVHD STUDY) |
| Date of disclosure of the study information | 2012/04/20 |
| Last modified on | 2019/04/25 10:12:25 |
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Basic information
Public title
A prospective observational study for a validation of National Institutes of Health criteria for late-acute and chronic GVHD
(KSGCT1201 / NIH-GVHD STUDY)
Acronym
KSGCT1201 / NIH-GVHD STUDY
Scientific Title
A prospective observational study for a validation of National Institutes of Health criteria for late-acute and chronic GVHD
(KSGCT1201 / NIH-GVHD STUDY)
Scientific Title:Acronym
KSGCT1201 / NIH-GVHD STUDY
Region
| Japan |
Condition
Condition
Allogeneic hematopoietic stem cell transplantation
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Prospectively assess the incidence of late-acute and chronic GVHD by revised NIH criteria (NIH-GVHD) and evaluate the impact of those on the outcome of stem cell transplantation.
Basic objectives2
Others
Basic objectives -Others
Describe the incidence and distribution of NIH-GVHD, and assess whether they predict the mortality and survival.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluate weather global severity of NIH-GVHD associates with GVHD specific survival and the time to immunosuppressant withdrawal.
Key secondary outcomes
Evaluate the association of classification and global severity of NIH-GVHD with following parameters;
Overall survival
Evaluate the association of classification and global severity of NIH-GVHD with following parameters;
Overall survival
Non-relapse mortality
Relapse rate
Incidence of secondary malignancy
Cumulative incidence of NIH-GVHD
Distribution of organ specific severity
Risk factor for the onset of NIH-GVHD
Treatment outcome of NIH-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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who undergo allogeneic stem cell transplantation for the first time
2. Age 16 or over at transplantation
3. Provided written informed consent in accordance with the Declaration of Helsinki.
Key exclusion criteria
Patients without written informed consent.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichiro Okamoto |
Organization
Kanto Study Group for Cell Therapy
Division name
Chairman
Zip code
Address
Tokyo
TEL
03-6225-2040
ksgctdc@ksgct.net
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chikako Ohwada |
Organization
Kanto Study Group for Cell Therapy
Division name
Trial Office
Zip code
Address
rm.B 4nd fl. Heiwa Building, 3-3-13, Kyobashi, Chuo-ku, Tokyo, 104-0031, Japan
TEL
03-6225-2040
Homepage URL
chikako_ohwada@faculty.chiba-u.jp
Sponsor or person
Institute
Kanto Study Group for Cell Therapy
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
Address
Tel
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
| 2012 | Year | 04 | Month | 20 | 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
Completed
Date of protocol fixation
| 2012 | Year | 03 | Month | 07 | Day |
Date of IRB
| 2012 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 04 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NIH-GVHD
Management information
Registered date
| 2012 | Year | 04 | Month | 20 | Day |
Last modified on
| 2019 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009183
