UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056981 |
|---|---|
| Receipt number | R000064478 |
| Scientific Title | Establishment of a Registry for Late Cardiotoxicity in Pediatric and Adolescent and Young Adult (AYA) Cancer Survivors |
| Date of disclosure of the study information | 2025/02/10 |
| Last modified on | 2025/02/08 17:20:54 |
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Basic information
Public title
Establishment of a Registry for Late Cardiotoxicity in Pediatric and Adolescent and Young Adult (AYA) Cancer Survivors
Acronym
Establishment of a Registry for Late Cardiotoxicity in Pediatric and Adolescent and Young Adult (AYA) Cancer Survivors
Scientific Title
Establishment of a Registry for Late Cardiotoxicity in Pediatric and Adolescent and Young Adult (AYA) Cancer Survivors
Scientific Title:Acronym
Establishment of a Registry for Late Cardiotoxicity in Pediatric and Adolescent and Young Adult (AYA) Cancer Survivors
Region
| Japan |
Condition
Condition
Pediatric and AYA Cancer Survivors
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to improve the survivorship of pediatric and AYA cancer patients by establishing a registry to address late cardiac toxicity and establish a long-term follow-up system.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of cardiotoxicity (heart failure, ischemic heart disease, hypertension, thromboembolism, arrhythmia)
Key secondary outcomes
Presence or absence of symptoms suggestive of heart failure (chest pain, dyspnea, palpitations, fatigue, lower limb edema) and degree of VAS
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who have been diagnosed with cancer who are children (under 15 years old) or in the AYA generation (15 years old or older but under 40 years old)
2) Patients who have a history of treatment for cancer
3) Patients who are 18 years old or older at the time of obtaining consent
Key exclusion criteria
(1) No exclusion criteria
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Minegishi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
236-0004
Address
3-9, Kanazawa, Fukuura, Yokohama
TEL
045-787-2635
minegishi.shi.fb@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Minegishi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
236-0004
Address
3-9, Kanazawa, Fukuura, Yokohama
TEL
045-787-2635
Homepage URL
minegishi.shi.fb@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Graduate School of Medicine
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
Yokohama City University Hospital
Address
3-9, Kanazawa, Fukuura, Yokohama
Tel
045-370-7627
rinri@yokohama-cu.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
| 2025 | Year | 02 | Month | 10 | 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
| 2024 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In this study, we will collect clinical data and blood samples from pediatric and AYA cancer survivors and establish a registry. By gathering this information, we aim to facilitate the search for biomarkers of late-onset cardiotoxicity and the development of testing methods necessary for long-term follow-up. This initiative is expected to contribute to the creation of a support system that enables cancer survivors to live with peace of mind after treatment and to advance the development of medical resources.
Management information
Registered date
| 2025 | Year | 02 | Month | 08 | Day |
Last modified on
| 2025 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064478
