UMIN-CTR Clinical Trial

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

Hematopoietic malignancy, breast cancer

Classification by specialty

Cardiology	Hematology and clinical oncology	Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Kurume University

Institute

Department

Personal name

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

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

10

Month

04

Day

URL releasing protocol

https://academic.oup.com/eurjpc/advance-article/doi/10.1093/eurjpc/zwad210/7205806

Publication of results

Published

URL related to results and publications

https://academic.oup.com/eurjpc/advance-article/doi/10.1093/eurjpc/zwad210/7205806

Number of participants that the trial has enrolled

533

Results

Over a median 716-day follow-up, CVR-CVT occurred in 24.3%, 15.8%, 38.1%, and 18.0% of leukemia, malignant lymphoma, multiple myeloma, and breast cancer patients respectively. High or very high-risk patients, identified by HFA-ICOS, had significantly more CVR-CVT events. The 1-year survival rates were 81.2%, 85.8%, 71.1%, and 91.7% for each respective cancer, with CV death in only 0.8% (four patients).

Results date posted

2023

Year

10

Month

10

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

This study initially enrolled 533 patients. After excluding 47 based on the exclusion criteria, 486 ultimately participated in this study. Among them, 397 patients had haematologic malignancies, and 89 had breast cancer. The median followup period was 716 days (IQR: 314-1266 days). Non-Hodgkin's lymphoma (67.3%) was the most common haematological malignancy among the enrolled patients, followed by multiple myeloma (15.9%), Hodgkin's lymphoma (4.5%), and acute myeloid leukaemia (3.8%). There were equal numbers of cases of left and right breast cancer (49.4% for both) and one case of bilateral breast cancer among the enrolled participants in this study. Their mean age was 63.8 plus minus 13.3 years, and 260 (53.5%) were females. Of them, 86 (96.6%) patients had breast cancer, and 174 (43.8%) had haematological malignancies. Approximately 145 (29.8%) patients had previously undergone anticancer therapy, 40 (8.2%) had a history of radiotherapy, and 76 (15.6%) had recurrent cancer. Comorbidities included hypertension in 178 patients (36.6%) and HF in 14 (2.9%) patients. Further, 154 (31.7%) patients had a smoking history. The median NT-proBNP titre was 107.1 (IQR: 48.6-232.5) pg/mL, and the mean LVEF was 65.9 plus minus 6.4%. Seven (1.4%) patients had an LVEF of <50% at baseline, and all had haematologic malignancies.

Participant flow

This study enrolled patients with haematologic malignancies and breast cancer aged >=20 years who meet the selection criteria. Our inclusion criteria were as follows: (i) age of >=20 years, (ii) presence of haematologic malignancies or breast cancer that is or will be treated with anticancer agents at Kurume University Hospital, and (iii) provision of written informed consent for study participation. Exclusion criteria were as follows: (i) a follow-up period of <=30 days, (ii) a predicted life expectancy of <=6 months, and (iii) no anticancer agent treatment during the study period. This study included patients with a history of cancer, anticancer therapy, radiation therapy, or known CV diseases. We enrolled all consecutive patients with haematologic malignancies and breast cancer scheduled for potentially cardiotoxic anticancer agents who were referred by oncologists to the Cardiology Unit of Kurume University Hospital from October 2016 to February 2021 after obtaining written informed content and were followed up until the end of August 2021. All the patients underwent transthoracic echocardiography, 12-lead electrocardiography, chest radiography, blood sampling, and urinalysis at enrolment. All tests except echocardiography were performed every 6 months during the follow-up period. The attending haematologists and breast surgeons determined the oncological treatment strategy. Patients visited the Cardiology Unit of Kurume University Hospital when clinical signs of suspected CV events or abnormal signs were observed every 6-month examination. Then, attending cardiologists performed echocardiography, lower-extremity venous ultrasonography, coronary angiography, or computed tomography, as necessary. All patients were followed up in oncology clinics, and CV events that occurred during the study period were treated and evaluated according to cardiology guidelines.

Adverse events

None

Outcome measures

The primary endpoints were the CV adverse events, defined by two or more attending cardiologists according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 Grade >=2.12 Individual CTCAE were grouped into heart failure (HF)/LV systolic dysfunction, acute coronary syndrome, venous thromboembolism, new arterial hypertension, atrial fibrillation, bradycardia, QT corrected interval prolongation, and pericardial effusion. The secondary endpoints were all-cause and CV deaths. The attending cardiologists evaluated all CV events during the follow-up period. Patients with pre-existing CV comorbidities who remained stable after enrolment in this study were not recorded as having any events.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

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 related information

none

Registered date

2016

Year

10

Month

04

Day

Last modified on

2023

Year

10

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027962