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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033773
Receipt No. R000037431
Scientific Title Keio Cardiovascular Study on Pathogenesis of Anticancer Drugs Contributing to Cardiovascular Events
Date of disclosure of the study information 2018/09/01
Last modified on 2019/08/16

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Basic information
Public title Keio Cardiovascular Study on Pathogenesis of Anticancer Drugs Contributing to Cardiovascular Events
Acronym Keio Onco-Cardiomics Study
Scientific Title Keio Cardiovascular Study on Pathogenesis of Anticancer Drugs Contributing to Cardiovascular Events
Scientific Title:Acronym Keio Onco-Cardiomics Study
Region
Japan

Condition
Condition Cancer
Classification by specialty
Medicine in general Cardiology Surgery in general
Obsterics and gynecology Dermatology Urology
Radiology Laboratory medicine
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 This study aims to investigate the frequency of cardiovascular events and factors associated with the onset of cardiovascular events among patients receiving chemotherapy to treat cancer. Furthermore, this aims to clarify pathologic mechanisms of anticancer therapies contributing to cardiovascular damages using comprehensive patients' information combined with a multi-omics approach.
Basic objectives2 Others
Basic objectives -Others Registration and follow-up
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Frequencies and types of cardiovascular events
2. Investigation of factors associated with the onset of cardiovascular events and clarification of pathogensis of anticancer therapies contributing to cardiovascular damages
Key secondary outcomes Changes in 1)biomarkers; 2)imagings; and 3)exercise tolerance before and after chemotherapy to treat cancer

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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Scheduled or received chemotharapy for tumors of hematopoietic and lymphoid tissue, lung, digestive tract, liver, pancreas, gallbladder and biliary tract, breast, genital and urinary tract, and skin
2. Expected to survive for more than 6 months
3. Provided informed consent
Key exclusion criteria ineligible for the study as judged by the investigator
Target sample size 5000

Research contact person
Name of lead principal investigator
1st name Masaharu
Middle name
Last name Kataoka
Organization Keio University School of Medicine
Division name Cardiology
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 0333531211
Email m.kataoka09@keio.jp

Public contact
Name of contact person
1st name Yasuyuki
Middle name
Last name Shiraishi
Organization Keio University School of Medicine
Division name Cardiology
Zip code 160-8582
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 0333531211
Homepage URL
Email yasshiraishi@keio.jp

Sponsor
Institute Keio University
Institute
Department

Funding Source
Organization Public and non-profit foundation
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Keio University School of Medicine Research Ethics Committee
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
Tel 0333531211
Email med-rinri-jimu@adst.keio.ac.jp

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 慶應義塾大学病院(東京)

Other administrative information
Date of disclosure of the study information
2018 Year 09 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 Enrolling by invitation
Date of protocol fixation
2018 Year 04 Month 12 Day
Date of IRB
2018 Year 05 Month 30 Day
Anticipated trial start date
2018 Year 09 Month 01 Day
Last follow-up date
2027 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information None

Management information
Registered date
2018 Year 08 Month 15 Day
Last modified on
2019 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037431

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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