UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003460 |
|---|---|
| Receipt number | R000004189 |
| Scientific Title | A prospective cohort study for the association of pretransplant iron overload with infection and outcome after allogeneic hematopoietic stem cell transplantation (F-STUDY) |
| Date of disclosure of the study information | 2010/04/07 |
| Last modified on | 2015/08/29 09:29:24 |
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Basic information
Public title
A prospective cohort study for the association of pretransplant iron overload with infection and outcome after allogeneic hematopoietic stem cell transplantation (F-STUDY)
Acronym
A prospective study for the association of pretransplant iron overload with infection after allogeneic HSCT (F-STUDY)
Scientific Title
A prospective cohort study for the association of pretransplant iron overload with infection and outcome after allogeneic hematopoietic stem cell transplantation (F-STUDY)
Scientific Title:Acronym
A prospective study for the association of pretransplant iron overload with infection after allogeneic HSCT (F-STUDY)
Region
| Japan |
Condition
Condition
AML,ALL,MDS
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the association of serum ferritin of pretransplant and day 100 after HSCT with infection early after HSCT and survival prospectively
Basic objectives2
Others
Basic objectives -Others
Infection during 100 days after HSCT
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Infection during 100 days after HSCT (pathogens, organs and cumulative incidence)
Key secondary outcomes
Day 100 nonrelapse mortality
1-y nonrelapse mortality
1-y overall survival
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
1.Patients with acute leukemia or myelodysplastic syndrome
2.The first time of allogeneic HSCT (no limitation of stem cell source, or HLA disparity)
3.20-y.o or older
4.No limitation of conditioning regimen, GVHD prophylaxis and supportive therapy
Key exclusion criteria
1.Past history of allogeneic HSCT
2.Without written informed concent
Target sample size
200
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 | Masatsugu Tanaka |
Organization
Kanto Study Group for Cell Therapy
Division name
Trial Office
Zip code
Address
kanagawa
TEL
045-520-2222
Homepage URL
tanakam@yokohama-cu.ac.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
| 2010 | Year | 04 | Month | 07 | 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
| 2010 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort study
Management information
Registered date
| 2010 | Year | 04 | Month | 07 | Day |
Last modified on
| 2015 | Year | 08 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004189
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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