UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035068 |
|---|---|
| Receipt number | R000039914 |
| Scientific Title | Observational study of the correlation between the geriatric assessment tools and prognosis of the geriatric patients with myelodysplastic syndrome (prospective observational study) |
| Date of disclosure of the study information | 2018/12/15 |
| Last modified on | 2018/12/27 16:09:26 |
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Basic information
Public title
Observational study of the correlation between the geriatric assessment tools and prognosis of the geriatric patients with
myelodysplastic syndrome (prospective observational study)
Acronym
Observational study of the correlation between the geriatric assessment tools and prognosis of the geriatric patients with
myelodysplastic syndrome (prospective observational study)
Scientific Title
Observational study of the correlation between the geriatric assessment tools and prognosis of the geriatric patients with
myelodysplastic syndrome (prospective observational study)
Scientific Title:Acronym
Observational study of the correlation between the geriatric assessment tools and prognosis of the geriatric patients with
myelodysplastic syndrome (prospective observational study)
Region
| Japan |
Condition
Condition
myelodysplastic syndrome
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We confirm whether the geriatric assessment tool can be myelodysplastic syndrome patients prognostic prediction
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
5 years survival rate stratified by geriatric assessment tool
Key secondary outcomes
monthly hospital days stratified by geriatric assessment tool
decrease rate of the score of EQ-5D-5L stratified by geriatric assessment tool
remission rate by treatment intensity stratified by geriatric assessment tool
survival rate by treatment intensity stratified by geriatric assessment tool
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
65 years of age or older
patients diagnosed with myelodysplastic syndrome
patients who got written informed consent
Key exclusion criteria
patients who treat chemotherapy for hematological malignancy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Suyama Takuya |
Organization
Hitachi general hospital
Division name
hematology,oncology
Zip code
Address
2-1-1 Jonan-cho,Hitachi City,Ibaraki prefecture
TEL
0294231111
sutaku2468@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Suyama Takuya |
Organization
Hitachi general hospital
Division name
hematology,oncology
Zip code
Address
2-1-1 Jonan-cho,Hitachi City,Ibaraki prefecture
TEL
0294231111
Homepage URL
sutaku2468@yahoo.co.jp
Sponsor or person
Institute
Hitachi general hospital
Institute
Department
Personal name
Funding Source
Organization
Hitachi general hospital
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
| 2018 | Year | 12 | 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
| 2018 | Year | 11 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 12 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
all patients who met the selection criteria in patients who visited our hospital forom December 2018 to December 2026
Items to be measured:age,sex,PS,G8,R-IPSS, Charlson comobidity index,EQ-5D-5L(registration,Half a year, 1 year, 2 year, 3 year, 4 year, 5 year),serum Alb,hospital days,Chemotherapy, treatment effect, presence or absence of relapse, survival date, date of death
Management information
Registered date
| 2018 | Year | 11 | Month | 29 | Day |
Last modified on
| 2018 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039914
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
