UMIN-CTR Clinical Trial

Basic information
Public title	Investigation into the specific brain network of with anti tumor agents by functional MRI
Acronym	Investigation into the specific brain network of with anti tumor agents by functional MRI
Scientific Title	Investigation into the specific brain network of with anti tumor agents by functional MRI
Scientific Title:Acronym	Investigation into the specific brain network of with anti tumor agents by functional MRI
Region	Japan

Condition
Condition	lung cancer, breast cancer
Classification by specialty	Chest surgery Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Investigation into treatment for patients given bevacizumab with lung or breast cancer an outbreak of cerebral vessel disorders
Basic objectives2	Bio-availability
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Investigation of side effects by anti tumor agents
Key secondary outcomes	Concentrations of VEGF

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	90 years-old >
Gender	Male and Female
Key inclusion criteria	Treatment with anti tumor agents. Ability to informed consent.
Key exclusion criteria	Devices of like pacemakers , plates, artificial joints. Claustrophobia. Disorders of audition. Cerebral vessels disorders.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name RIKA NOGAWA
Organization	Wakayama medica school
Division name	Anesthegiology
Zip code
Address	811-1, Kimiidera, Wakayama-city, Wakayama JAPAN
TEL	073-447-2300
Email	rikan@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name RIKA NOGAWA
Organization	Wakayama medical school
Division name	Anesthegiology
Zip code
Address	811-1, Kimiidera, Wakayama-city, Wakayama JAPAN
TEL	073-447-2300
Homepage URL
Email	rikan@wakayama-med.ac.jp

Sponsor
Institute	Wakayama medical School
Institute
Department

Funding Source
Organization	Wakayama medical school
Organization
Division
Category of Funding Organization	Local Government
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	2015 Year 03 Month 31 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	Terminated
Date of protocol fixation	2014 Year 02 Month 20 Day
Date of IRB	2015 Year 03 Month 01 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We take functional MRIs of patients with anti tumor agents, search the existences of cerebral vessel disorders.

Management information
Registered date	2015 Year 03 Month 08 Day
Last modified on	2022 Year 09 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019428