UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033773
Receipt number 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 2023/08/20 19:46:15

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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
Obstetrics 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 Yoshinori
Middle name
Last name Katsumata

Organization

Keio University School of Medicine

Division name

Cardiology

Zip code

160-8582

Address

35 Shinanomachi, Shinjuku-ku, Tokyo

TEL

0333531211

Email

goodcentury21@gmail.com


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 or person

Institute

Keio University

Institute

Department

Personal name



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(東京都)
産業医科大学(福岡県)


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

2023 Year 08 Month 20 Day



Link to view the page

Value
https://center6.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