UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000851 |
|---|---|
| Receipt number | R000001021 |
| Scientific Title | Impact of comorbidities on the outcome of allogeneic hematopoietic stem cell transplantation |
| Date of disclosure of the study information | 2007/11/01 |
| Last modified on | 2013/11/05 13:46:08 |
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Basic information
Public title
Impact of comorbidities on the outcome of allogeneic hematopoietic stem cell transplantation
Acronym
comorbidities on allo HCT
Scientific Title
Impact of comorbidities on the outcome of allogeneic hematopoietic stem cell transplantation
Scientific Title:Acronym
comorbidities on allo HCT
Region
| Japan |
Condition
Condition
hematologic diseases
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
confirm the utility of HCT-CI in predicting non-relapse mortality and overall survival after HCT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
non-relapse mortality and overall survival
Key secondary outcomes
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
all patients who receive HCT for the first time
Key exclusion criteria
patients who receive second HCT
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichiro Okamoto |
Organization
Keio University School of Medicine
Division name
Division of Hematology
Zip code
Address
35 Shinamomachi, Shinjyuku-ku, Tokyo
TEL
03-3353-1211
okamoto@sc.itc.keio.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Aya Nakaya |
Organization
Keio University School of Medicine
Division name
Division of Hematology
Zip code
Address
35 Shinamomachi, Shinjyuku-ku, Tokyo
TEL
03-3353-1211
Homepage URL
nakaya1016@yahoo.co.jp
Sponsor or person
Institute
KSGCT
Institute
Department
Personal name
Funding Source
Organization
KSGCT
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
| 2007 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2007 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 09 | Month | 09 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
(1)calculate HCT-CI before HCT
(2)follow patients for 2 years after HCT
(3)confirm the utility of HCT-CI in predicting NRM and OS after HCT
Management information
Registered date
| 2007 | Year | 10 | Month | 15 | Day |
Last modified on
| 2013 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001021
