UMIN-CTR Clinical Trial

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
Institute	Kumamoto University
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047554