UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022703 |
|---|---|
| Receipt number | R000026122 |
| Scientific Title | Multidisciplinary analysis of neurological findings and their chronological changes in patients with ifosfamide-induced encephalopathy. |
| Date of disclosure of the study information | 2016/06/11 |
| Last modified on | 2020/06/16 13:29:43 |
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Basic information
Public title
Multidisciplinary analysis of neurological findings and their chronological changes in patients with ifosfamide-induced encephalopathy.
Acronym
Multidisciplinary analysis of neurological findings and their chronological changes in patients with ifosfamide-induced encephalopathy.
Scientific Title
Multidisciplinary analysis of neurological findings and their chronological changes in patients with ifosfamide-induced encephalopathy.
Scientific Title:Acronym
Multidisciplinary analysis of neurological findings and their chronological changes in patients with ifosfamide-induced encephalopathy.
Region
| Japan |
Condition
Condition
malignant solid tumor
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To observate ifosfamide induced encephalopathy
Basic objectives2
Others
Basic objectives -Others
to analyse chronological changes of electroencephalogram, MRI and FGD-PET
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
neurological and pshychological symptoms
Key secondary outcomes
electroencephalogram
MRI
FGD-PET
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
| 7 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients with malignant solid tumor and undergo high dose ifosfamide therapy
under 40 years old
Key exclusion criteria
patient with brain metastasis
patients who have neurological and/or psychological symptom
poor performance status
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Atsuko |
| Middle name | |
| Last name | Watanabe |
Organization
Saitama Medical University International Medical Center
Division name
Department of Pediatric Oncology
Zip code
350-1298
Address
1397-1 Yamane, Hidaka-shi, Saitama
TEL
042-984-4111
atsuko_w@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Atsuko |
| Middle name | |
| Last name | Watanabe |
Organization
Saitama Medical University International Medical Center
Division name
Department of Pediatric Oncology
Zip code
350-1298
Address
1397-1 Yamane, Hidaka-shi, Saitama
TEL
042-984-4111
Homepage URL
atsuko_w@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University International Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University International Medical Center
Address
1397-1 Yamane, Hidaka-shi, Saitama
Tel
042-984-4111
atsuko_w@saitama-med.ac.jp
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
| 2016 | Year | 06 | Month | 11 | 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
Completed
Date of protocol fixation
| 2016 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 12 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2016 | Year | 06 | Month | 11 | Day |
Last modified on
| 2020 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026122
| 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 |
