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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000024278
Receipt No. R000027962
Scientific Title Kurume University Cardio-Renal Oncology Registry
Date of disclosure of the study information 2016/10/04
Last modified on 2019/04/08

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Basic information
Public title Kurume University Cardio-Renal Oncology Registry
Acronym Kurume-CREO Registry
Scientific Title Kurume University Cardio-Renal Oncology Registry
Scientific Title:Acronym Kurume-CREO Registry
Region
Japan

Condition
Condition Hematopoietic malignancy, breast cancer
Classification by specialty
Cardiology Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study designed for comprehensive data collection and evaluation of the current practice in terms of diagnosis and management of chemotherapy-related cardiac toxicity and kidney disorder in hematopoietic malignancy and breast cancer patients.
Basic objectives2 Others
Basic objectives -Others Registration and follow-up
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) New Grade2-4 cardiac disorder (cardiomyopathy, ischemic heart disease, arrhythmia and others) and vascular disorder (thromboembolic event) in CTCAE v4.0-JCOG
2) Progression of renal damage (requiring dialysis and doubling of serum creatinine)
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Age above 20
2. Can understand the consept of this study and agree with own accord
3. Hematologic malignancies or breast cancer patients receiving chemotherapy in Kurume University Hospital (both inpatient and outpatient)
4. Expected to more than 6 months of survival
Key exclusion criteria 1. Patients as deemed appropriate for participation in this trial by medical doctors
Target sample size 1400

Research contact person
Name of lead principal investigator
1st name Yoshihiro
Middle name
Last name Fukumoto
Organization Kurume University School of Medicine
Division name Department of Internal Medicine, Division of Cardiovascular Medicine
Zip code 830-0011
Address 67 Asahi-machi, Kurume city Fukuoka, JAPAN
TEL 0942-31-7562
Email fukumoto_yoshihiro@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name Tatsuhiro
Middle name
Last name Shibata
Organization Kurume University School of Medicine
Division name Department of Internal Medicine, Division of Cardiovascular Medicine
Zip code 8300011
Address 67 Asahi-machi, Kurume city Fukuoka, JAPAN
TEL 0942-31-7562
Homepage URL
Email shibata_tatsuhiro@med.kurume-u.ac.jp

Sponsor
Institute Kurume University
Institute
Department

Funding Source
Organization Kurume University School of Medicine
Department of Internal Medicine, Division of Cardiovascular 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 Industry-Academia-Government Collaboration Office, Kurume University
Address 67 Asahi-machi, Kurume city, Fukuoka, JAPAN
Tel 0942-31-7917
Email sangaku@kurume-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
2016 Year 10 Month 04 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
2016 Year 10 Month 04 Day
Date of IRB
2016 Year 08 Month 31 Day
Anticipated trial start date
2016 Year 10 Month 11 Day
Last follow-up date
2021 Year 08 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
2016 Year 10 Month 04 Day
Last modified on
2019 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027962

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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