UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060275 |
|---|---|
| Receipt number | R000068948 |
| Scientific Title | A Multicenter Observational Study Investigating the Development of Cardiovascular Diseases in Cancer Patients and Cancer-associated Genome Profiling |
| Date of disclosure of the study information | 2026/01/07 |
| Last modified on | 2026/01/07 11:02:10 |
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Basic information
Public title
A Multicenter Observational Study Investigating the Development of Cardiovascular Diseases in Cancer Patients and Cancer-associated Genome Profiling
Acronym
ONCO CARDIO Registry
Scientific Title
A Multicenter Observational Study Investigating the Development of Cardiovascular Diseases in Cancer Patients and Cancer-associated Genome Profiling
Scientific Title:Acronym
ONCO CARDIO Registry
Region
| Japan |
Condition
Condition
Cancer patients who underwent gene panel testing
Classification by specialty
| Cardiology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study aims to establish a large epidemiological database in the field of cardio-oncology that incorporates comprehensive cancer-related gene profiling data from patients with cancer, and to integratively analyze clinical and genetic information.
Basic objectives2
Others
Basic objectives -Others
The significance of this study lies in its ability to precisely predict, at the individual patient level, the risk of developing cardiovascular diseases associated with cancer treatment, thereby maximizing the effectiveness of anticancer therapies.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Venous thromboembolism, Heart failure, Hypertension, Acute myocardial infarction, Atrial fibrillation/flutter, Stroke, Death, Major bleeding
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
| 18 | years-old | <= |
Age-upper limit
| 110 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Cases registered in the Center for Cancer Genomics and Advanced Therapeutics (C-CAT) at the National Cancer Center, with consent provided for secondary use of their data.
Key exclusion criteria
NA
Target sample size
15000
Research contact person
Name of lead principal investigator
| 1st name | Yugo |
| Middle name | |
| Last name | Yamashita |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
606-8507
Address
54 Shogoin-Kawaharacho Sakyo-ku, Kyoto
TEL
+81-75-751-4255
yyamashi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Kanna |
| Middle name | |
| Last name | Nakamura |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
606-8507
Address
54 Shogoin-Kawaharacho Sakyo-ku, Kyoto
TEL
+81-75-751-4255
Homepage URL
yyamashi@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto
Tel
075-366-7618
ethcom@kuhp.kyoto-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
| 2026 | Year | 01 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2026 | Year | 01 | Month | 06 | Day |
Last modified on
| 2026 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068948
