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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032779
Receipt No. R000037395
Scientific Title Observational registry of cardiac function, hemodynamics, Frailty and depressive disorder in Japanese cancer patients visited onco-cardiology outpatient
Date of disclosure of the study information 2018/06/01
Last modified on 2018/11/29

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Basic information
Public title Observational registry of cardiac function, hemodynamics, Frailty and depressive disorder in Japanese cancer patients visited onco-cardiology outpatient
Acronym Observational registry of cardiac function, hemodynamics, Frailty and depressive disorder in Japanese cancer patients visited onco-cardiology outpatient
Scientific Title Observational registry of cardiac function, hemodynamics, Frailty and depressive disorder in Japanese cancer patients visited onco-cardiology outpatient
Scientific Title:Acronym Observational registry of cardiac function, hemodynamics, Frailty and depressive disorder in Japanese cancer patients visited onco-cardiology outpatient
Region
Japan

Condition
Condition Onco-Cardiology
Classification by specialty
Medicine in general Cardiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify cardiac function, hemodynamics, Frailty and depressive disorder in Japanese cancer patients visited onco-cardiology outpatient
Basic objectives2 Others
Basic objectives -Others To clarify the prognosis in Japanese cancer patients visited onco-cardiology outpatient
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes cardiac function, hemodynamics, frailty and depressive disorder score by PHQ-9 within one month from first visit
Key secondary outcomes 1all cause death
2heart failure event
3artery thromboembolus event
4venous thromboembolus event
5Bleeding event
6blood pressere worsening

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
15 years-old <
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria patients with agreement for this study
Key exclusion criteria 1patients without agrreement for this study
2inappropiriate patients determined from study director
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiaki Higashitani
Organization Tokyo Medical University Ibaraki Medical Center
Division name Department of cardiology
Zip code
Address 3-20-1 Amimachi Chuo Inashikigun Ibaraki
TEL 029-887-1161
Email mhigashi@tokyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Michiaki Higashitani
Organization Department of cardiology office
Division name Department of cardiology office
Zip code
Address 3-20-1 Amimachi Chuo Inashikigun Ibaraki
TEL 029-887-1161
Homepage URL
Email mhigashi@tokyo-med.ac.jp

Sponsor
Institute Department of cardiology office
Institute
Department

Funding Source
Organization Department of cardiology office
Organization
Division
Category of Funding Organization Self funding
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
2018 Year 06 Month 01 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 Open public recruiting
Date of protocol fixation
2018 Year 05 Month 22 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observational study

Management information
Registered date
2018 Year 05 Month 30 Day
Last modified on
2018 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037395

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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