UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051698 |
|---|---|
| Receipt number | R000054656 |
| Scientific Title | Cardiovascular adverse events in lung cancer patients receiving immune checkpoint inhibitor therapy: An analysis of a nationwide electronic medical record data |
| Date of disclosure of the study information | 2023/08/30 |
| Last modified on | 2025/06/24 19:34:36 |
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Basic information
Public title
Cardiovascular adverse events in lung cancer patients receiving immune checkpoint inhibitor therapy: An analysis of a nationwide electronic medical record data
Acronym
CARE in ICI therapy
Scientific Title
Cardiovascular adverse events in lung cancer patients receiving immune checkpoint inhibitor therapy: An analysis of a nationwide electronic medical record data
Scientific Title:Acronym
CARE in ICI therapy
Region
| Japan |
Condition
Condition
Patients with primary lung cancer
Classification by specialty
| Cardiology | Pneumology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The incidence, clinical characteristics, and risk factors of cardiovascular adverse events during immune checkpoint inhibitor (ICI) therapy in primary lung cancer patients have not been adequately evaluated since these adverse events are not common. This study aims to investigate the impact of ICI therapy on clinically evident cardiovascular adverse events in patients with primary lung cancer using a nationwide electronic medical record data.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
The following outcomes that occur within 180 days after the index date.
1. Any myocarditis
2. Severe myocarditis, including fulminant form of myocarditis
3. Acute myocardial infarction, unstable angina pectoris, and spastic angina pectoris
4. Symptomatic arrhythmias
5. Pericarditis
6. Sudden death and acute cardiac death
7. Acute heart failure requiring hospital admission
8. Deep vein thrombosis
9. Takotsubo cardiomyopathy
Index date is defined as the time of the first ICI treatment (study group) or the time of the first start of predefined chemotherapy other than ICI (control group).
Key secondary outcomes
The following outcomes that occur within 180 days after the index date.
1. Myasthenia gravis
2. Myositis
3. Polymyalgia rheumatica,
4. Hyperthyroidism/Hypothyroidism
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with primary lung cancer
Key exclusion criteria
1) Patients with previous diagnosis of the following diseases are excluded from the analysis:
Multiple myeloma
BCR-ABL-positive chronic myelogenous leukemia
Cervical cancer
Ovarian cancer
Hepatocellular carcinoma
Gastric cancer
Rectal cancer
Colon cancer
3)Patients without a 180-day look-back period commencing at the time of first ICI treatment (study group) or at the time of the first start of predefined chemotherapy other than ICI (control group).
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Isawa |
Organization
Sendai Kousei Hospital
Division name
Cardiology Department
Zip code
980-0871
Address
Hirosemachi 4-15, Sendai city, Miyagi prefecture, Japan
TEL
+81222226181
isa_tsuyo@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Isawa |
Organization
Sendai Kousei Hospital
Division name
Cardiology Department
Zip code
980-0871
Address
Hirosemachi 4-15, Sendai city, Miyagi prefecture, Japan
TEL
+81222226181
Homepage URL
isa_tsuyo@yahoo.co.jp
Sponsor or person
Institute
Sendai Kousei Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Sendai Kousei Hospital
Address
Hirosemachi 4-15, Sendai city, Miyagi prefecture, Japan
Tel
+81222226181
isa_tsuyo@yahoo.co.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
| 2023 | Year | 08 | Month | 30 | Day |
Related information
URL releasing protocol
https://academic.oup.com/oncolo/article/doi/10.1093/oncolo/oyaf151/8171908?utm_source=authortollfree
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/oncolo/article/doi/10.1093/oncolo/oyaf151/8171908?utm_source=authortollfree
Number of participants that the trial has enrolled
1486
Results
The study included 743 propensity-matched patients in each cohort. The median follow-up period was 329 days (interquartile range, 147-625). At 180 days, 4.0% of ICI-treated patients experienced MACEs, significantly higher than those treated with non-ICI chemotherapy (hazard ratio [HR], 1.98; 95% confidence interval [CI], 1.07-3.69; P-value = .030).
Results date posted
| 2025 | Year | 06 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The matched ICI and matched non-ICI cohorts are well balanced with respect to baseline characteristics.
Participant flow
The database, containing patient-related data from May 1, 2016 to April 30, 2021, was examined. Patients with primary lung cancer were identified using ICD-10 codes (C34.0, C34.1, C34.2, C34.3, or C34.9), Japan-specific medical procedure codes, and individual drug codes unique to the National Health Insurance drug price standard used in insurance claims in Japan (YJ codes). The accuracy of identifying patients with primary lung cancer in this database was very high, with approximately 99% of patients assigned a relevant diagnostic code having confirmed disease.15 The following patients were excluded from this study: (1) the following patients were excluded from this study: (1) those with secondary pulmonary tumors originating from non-pulmonary primary cancers (ICD-10 code C78.0); (2) those without a minimum look-back period of 180 days before cohort entry; (3) those with prior use of anthracyclines with high cardiotoxicity potential, including doxorubicin, daunorubicin, epirubicin, idarubicin, pirarubicin, and amrubicin, during the look-back period; and (4) those with a history of specific malignancies, including multiple myeloma, chronic myelogenous leukemia, cervical cancer, ovarian cancer, hepatocellular carcinoma, gastric cancer, rectal cancer, colon cancer, malignant lymphoma, breast cancer, and urothelial cancer, for which highly cardiotoxic antimalignancy drugs, such as proteasome inhibitors, tyrosine kinase inhibitors, vascular endothelial growth factor inhibitors, rituximab, and anthracycline antitumor agents, are widely employed in clinical practice.
Adverse events
A composite of MACEs at 180 days, comprising one or more of the following events: myocarditis; acute coronary syndromes, including myocardial infarction, unstable angina pectoris, and vasospastic angina; clinically relevant arrhythmias; heart failure; cardiac or sudden death; and pericarditis, was the primary outcome.
Outcome measures
A composite of MACEs at 180 days, comprising one or more of the following events: myocarditis; acute coronary syndromes, including myocardial infarction, unstable angina pectoris, and vasospastic angina; clinically relevant arrhythmias; heart failure; cardiac or sudden death; and pericarditis, was the primary outcome.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2023 | Year | 07 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This population-based, retrospective, observational cohort study utilized a real-word data database administered by the Health, Clinic, and Education Information Evaluation Institute (HCEI) (Kyoto, Japan) with the support of Real World Data, Co., Ltd. (Kyoto, Japan).
Management information
Registered date
| 2023 | Year | 07 | Month | 24 | Day |
Last modified on
| 2025 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054656
