UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000399 |
|---|---|
| Receipt number | R000000459 |
| Scientific Title | Cohort study to investigate the clinical factors associated with the prognosis of high risk myelodysplastic syndrome (MDS) and MDS/secondary AML |
| Date of disclosure of the study information | 2006/04/17 |
| Last modified on | 2018/10/04 18:08:07 |
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Basic information
Public title
Cohort study to investigate the clinical factors associated with the prognosis of high risk myelodysplastic syndrome (MDS) and MDS/secondary AML
Acronym
Cohort study for the prognosis of high risk MDS and MDS/secondary AML
Scientific Title
Cohort study to investigate the clinical factors associated with the prognosis of high risk myelodysplastic syndrome (MDS) and MDS/secondary AML
Scientific Title:Acronym
Cohort study for the prognosis of high risk MDS and MDS/secondary AML
Region
| Japan |
Condition
Condition
High risk myelodysplastic syndrome and MDS/secondary AML
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze the various factors associated with the prognosis of high risk MDS and MDS/secondary AML
Basic objectives2
Others
Basic objectives -Others
Survival limiting factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Efficacy of allo-stem cell transplantation in the survival of high risk MDS and MDS/secondary AML
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
| 15 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with high risk MDS and MDS/secondary AML
Age above 15 years old
Key exclusion criteria
none
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Matsuda, MD, PhD |
Organization
Kinki University School of Medicine
Division name
Department of Hematology
Zip code
Address
377-2 Ohno-Higashi, Osaka-Sayama, Osaka
TEL
072-366-0221
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mitsuhiro Matsuda, MD, PhD |
Organization
JALSG MDS206 study office
Division name
Department of Hematology, Kinki University School of Medicine
Zip code
Address
377-2 Ohno-Higashi, Osaka-Sayama, Osaka
TEL
072-366-0221
Homepage URL
mmatsuda@med.kindai.ac.jp
Sponsor or person
Institute
Japan Adult Leukemia Study Group
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labor and Welfare
Organization
Division
Category of Funding Organization
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
| 2006 | Year | 04 | Month | 17 | 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
Terminated
Date of protocol fixation
| 2006 | Year | 04 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The aim of this study is to analyze the various clinical factors such as chemotherapy, stem cell transplantation associated with the prognosis of high risk MDS and MDS/secondary MDS.
Management information
Registered date
| 2006 | Year | 04 | Month | 08 | Day |
Last modified on
| 2018 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000459
