UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045346
Receipt number R000047554
Scientific Title Study on cancer patient parameters.
Date of disclosure of the study information 2021/09/02
Last modified on 2021/09/02 07:16:39

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Basic information

Public title

KUMAMON cancer registry

Acronym

KUMAMON cancer registry

Scientific Title

Study on cancer patient parameters.

Scientific Title:Acronym

Study on cancer patient parameters.

Region

Japan


Condition

Condition

malignant disease

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The progress in cancer treatment has been remarkable, and in addition to surgical treatment, chemotherapy with various targeted drugs and new radiation therapy have been developed, and the survival rate of cancer patients has been greatly improved. Along with this, there are some reports that the onset of cardiovascular disease affects the prognosis of cancer patients.

Basic objectives2

Others

Basic objectives -Others

Currently, studies are underway to identify new biomarkers for the pathogenesis of cardiovascular disease such as arteriosclerosis and coronary artery disease in cancer patients. This time, in this study, diagnosis of various cardiovascular diseases (ischemic heart disease/peripheral artery disease, cardiomyopathy, heart failure, arrhythmia, valvular heart disease, aortic aneurysm, aortic dissection, venous thrombosis), determination of severity and therapeutic effect, We will search for biomarkers that can be prognostic and examine their usefulness.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

all cause mortality

Key secondary outcomes



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

1 years-old <=

Age-upper limit

120 years-old >

Gender

Male and Female

Key inclusion criteria

Cancer patients who are registered in the Cancer Registration Section of our hospital.

Key exclusion criteria

none

Target sample size

35000


Research contact person

Name of lead principal investigator

1st name Daisuke
Middle name
Last name Sueta

Organization

Kumamoto University

Division name

Cardiovascular Medicine

Zip code

860-8556

Address

1-1-1, Honjo, Kumamoto

TEL

096-373-5175

Email

sueta-d@kumamoto-u.ac.jp


Public contact

Name of contact person

1st name Daisuke
Middle name
Last name Sueta

Organization

Kumamoto University

Division name

Cardiovascular Medicine

Zip code

860-8556

Address

1-1-1, Honjo, Kumamoto

TEL

096-373-5175

Homepage URL


Email

sueta-d@kumamoto-u.ac.jp


Sponsor or person

Institute

Kumamoto University

Institute

Department

Personal name



Funding Source

Organization

self-funding

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

Kumamoto University

Address

1-1-1, Honjo, Kumamoto

Tel

096-373-5175

Email

sueta-d@kumamoto-u.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



Other administrative information

Date of disclosure of the study information

2021 Year 09 Month 02 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

Suspended

Date of protocol fixation

2021 Year 09 Month 01 Day

Date of IRB

2020 Year 02 Month 20 Day

Anticipated trial start date

2021 Year 10 Month 01 Day

Last follow-up date

2025 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

observation study


Management information

Registered date

2021 Year 09 Month 02 Day

Last modified on

2021 Year 09 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047554