UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004013 |
|---|---|
| Receipt number | R000004748 |
| Scientific Title | Brain magnetic resonance spectroscopic study among cancer patients with chemotherapy |
| Date of disclosure of the study information | 2010/08/06 |
| Last modified on | 2012/09/20 14:51:38 |
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Basic information
Public title
Brain magnetic resonance spectroscopic study among cancer patients with chemotherapy
Acronym
Brain magnetic resonance spectroscopic study among cancer patients with chemotherapy
Scientific Title
Brain magnetic resonance spectroscopic study among cancer patients with chemotherapy
Scientific Title:Acronym
Brain magnetic resonance spectroscopic study among cancer patients with chemotherapy
Region
| Japan |
Condition
Condition
breast cancer
Classification by specialty
| Medicine in general | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine effect of chemotherapy on neurochemicals among breast cancer patients
Basic objectives2
Others
Basic objectives -Others
To examine the effect of chemotherapy for quality of life
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in density of GABA in brain
Key secondary outcomes
Changes in density of another amino acid in brain
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patients with pathological diagnosis of breast cancer
2.Patients who are informed of their diagnosis
3.Patients with Performance status of 0-1
4.Patients was with full written consent
5.Patients who will undergo surgical operation
6.Patients will or will not be treated by adjuvant chemotherapy (doxorubicin and cyclophosphamide followed by a taxan)
Key exclusion criteria
1.Patients who is not able to understand this study because of dementia, delirium, or other cognitive disorder
2.Patients who is not able to understand this study because of major depression, schizophrenia, bipolar disorder or other psychiatric disorder
3.Patients for whom MRI is contraindicated
4.Patients with epilepsy, meningitis and neural degnerative disorder
5.Patients with brain metastasis
6.Patients with recurrent breast cancer
7.Patients with bilateral breast cancer
8.Patients with past history of any other cancer
9.Patients who have undergone chemotherapy before this study
10.Patients with serious somatic disease
11.Patients who are judged to be inappropriate for this study by their physician in charge
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Asao Ogawa |
Organization
Reserch Center for Innovative Oncology National Cancer Center Hospital East
Division name
Psycho-Oncology Division
Zip code
Address
6-5-1,Kashiwanoha, Kashiwa, Chiba, Japan
TEL
04-7134-7013
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Asao Ogawa |
Organization
Reserch Center for Innovative Oncology National Cancer Center Hospital East
Division name
Psycho-Oncology Division
Zip code
Address
6-5-1,Kashiwanoha, Kashiwa, Chiba, Japan
TEL
04-7134-7013
Homepage URL
asogawa@east.ncc.go.jp
Sponsor or person
Institute
Reserch Center for Innovative Oncology National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Grant from Health and Labor Sciences Reserch Grants, the third-term comprehensive control reserch for cancer
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
| 2010 | Year | 08 | Month | 06 | 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
| 2010 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will investigate relationship between chemotherapy and metabolism of amino acid in central nervous system.
Management information
Registered date
| 2010 | Year | 08 | Month | 06 | Day |
Last modified on
| 2012 | Year | 09 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004748
| 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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