UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017862 |
|---|---|
| Receipt number | R000020696 |
| Scientific Title | Significance of WT1 mRNA in the clinical course of lower-risk myelodysplastic syndromes. |
| Date of disclosure of the study information | 2015/06/15 |
| Last modified on | 2015/06/10 18:23:48 |
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Basic information
Public title
Significance of WT1 mRNA in the clinical course of lower-risk myelodysplastic syndromes.
Acronym
Significance of WT1 mRNA in the clinical course of lower-risk myelodysplastic syndromes.
Scientific Title
Significance of WT1 mRNA in the clinical course of lower-risk myelodysplastic syndromes.
Scientific Title:Acronym
Significance of WT1 mRNA in the clinical course of lower-risk myelodysplastic syndromes.
Region
| Japan |
Condition
Condition
lower-risk myelodysplastic syndromes
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine prognostic impacts of the value of WT1 mRNA in lower-risk MDS patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Impacts of the value of WT1 mRNA on 2 year overall survival
Key secondary outcomes
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
blood collection
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
Patients who were diagnosed with MDS or ICUS, and meets the categories below;
1: classified as RCUD, RCMD, MDS-U or ICUS
2: more than 20 years old
3: from whom we can obtain documented informed consent.
Key exclusion criteria
None
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Suzuki |
Organization
Jichi Medical University
Division name
Division of Hematology, Department of Medicine
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
TEL
0285-58-7353
tasuzuki@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahiro Suzuki |
Organization
Jichi Medical University
Division name
Division of Hematology, Department of Medicine
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
TEL
0285-58-7353
Homepage URL
tasuzuki@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
National Research Group on Idiopathic Bone Marrow Failure Syndromes in Japan
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
| 2015 | Year | 06 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 05 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 10 | Day |
Last modified on
| 2015 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020696
