UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026290 |
|---|---|
| Receipt number | R000030176 |
| Scientific Title | Investigation for the evaluation of the cognitive functional decline by the anticancer drug in Japanese. |
| Date of disclosure of the study information | 2017/02/24 |
| Last modified on | 2017/02/24 15:54:16 |
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Basic information
Public title
Investigation for the evaluation of the cognitive functional decline by the anticancer drug in Japanese.
Acronym
Investigation for the evaluation of the cognitive functional decline by the anticancer drug in Japanese.
Scientific Title
Investigation for the evaluation of the cognitive functional decline by the anticancer drug in Japanese.
Scientific Title:Acronym
Investigation for the evaluation of the cognitive functional decline by the anticancer drug in Japanese.
Region
| Japan |
Condition
Condition
healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish the system by the recommendation for appropriate Japanese cancer patients to demonstration a decline in cognitive function following chemotherapy for Japanese.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Score of the Wechsler Adult Intelligence Scale-III (WAIS-III), the Mini Mental State Examination (MMSE), Trail Making Test (TMT) A and B, Controlled Oral Word Association test (COWA) and Grooved Pegboard Test (PEG).
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Student of Showa University school of Pharmacy 20 years or older.
Key exclusion criteria
The person who has a medical examination in psychiatry, psychosomatic medicine, cranial nerve internal medicine or either neurosurgical regularly.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Iwai |
Organization
Showa university school of pharmacy
Division name
Healthcare and Regulatory Sciences
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8215
s-iwai@pharm.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kosuke Takata |
Organization
Showa university school of pharmacy
Division name
Healthcare and Regulatory Sciences
Zip code
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
TEL
03-3784-8215
Homepage URL
k.takata@cmed.showa-u.ac.jp
Sponsor or person
Institute
Showa university
Institute
Department
Personal name
Funding Source
Organization
Showa university
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
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
| 2017 | Year | 02 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 02 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2017 | Year | 02 | Month | 24 | Day |
Last modified on
| 2017 | Year | 02 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030176
