UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational registry of cardiac function, hemodynamics, Frailty and depressive disorder in Japanese cancer patients visited onco-cardiology outpatient
Title of the study (Brief title)	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	Michiaki Higashitani
Organization	Tokyo Medical University Ibaraki Medical Center
Division name	Department of cardiology
Address	3-20-1 Amimachi Chuo Inashikigun Ibaraki
TEL	029-887-1161
Email	mhigashi@tokyo-med.ac.jp

Public contact
Name of contact person	Michiaki Higashitani
Organization	Department of cardiology office
Division name	Department of cardiology office
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2018 Year 05 Month 22 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000037395