UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032779 |
|---|---|
| Receipt number | 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 09:36:22 |
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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
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
mhigashi@tokyo-med.ac.jp
Sponsor or person
Institute
Department of cardiology office
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037395
