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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004013
Receipt No. 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

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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
Email

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
Email asogawa@east.ncc.go.jp

Sponsor
Institute Reserch Center for Innovative Oncology National Cancer Center Hospital East
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004748

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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