UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010330 |
|---|---|
| Receipt number | R000012091 |
| Scientific Title | Comprehensive assessment of chemotherapy-induced cognitive dysfunction in patients with breast cancer |
| Date of disclosure of the study information | 2013/03/27 |
| Last modified on | 2013/03/27 16:34:09 |
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Basic information
Public title
Comprehensive assessment of chemotherapy-induced cognitive dysfunction in patients with breast cancer
Acronym
Asssement of chemobrain
Scientific Title
Comprehensive assessment of chemotherapy-induced cognitive dysfunction in patients with breast cancer
Scientific Title:Acronym
Asssement of chemobrain
Region
| Japan |
Condition
Condition
patients with breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To confirm the method how to assess cognitive dysfunction following to chemotherapy for breast cancer, and validate the biomaker
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with breast cancer, who have received chemotherapy (including the aromatase inhibitor)
Key exclusion criteria
Patients with obvious neurological deficit before recieving chemotherapy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideko Yamauchi |
Organization
St. Luke international hospital
Division name
Breast Center
Zip code
Address
Akashi 9-1, Chuouku, Tokyo, Japan
TEL
03-3541-5151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Sumitani |
Organization
The University of Tokyo Hospital
Division name
Department of Medical Engineering
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
St. Luke international hospital
Institute
Department
Personal name
Funding Source
Organization
MHLW
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
聖路加国際病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 03 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cognitive assessment
Management information
Registered date
| 2013 | Year | 03 | Month | 27 | Day |
Last modified on
| 2013 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012091
