UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032729 |
|---|---|
| Receipt number | R000037322 |
| Scientific Title | A prospective observational study of patients with advanced cancer for the evaluation of checkpoint inhibitor-associated cardiovascular immune-related adverse events |
| Date of disclosure of the study information | 2018/05/26 |
| Last modified on | 2022/05/31 20:33:42 |
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Basic information
Public title
A prospective observational study of patients with advanced cancer for the evaluation of checkpoint inhibitor-associated cardiovascular immune-related adverse events
Acronym
AWARENESS-irAE registry
Scientific Title
A prospective observational study of patients with advanced cancer for the evaluation of checkpoint inhibitor-associated cardiovascular immune-related adverse events
Scientific Title:Acronym
AWARENESS-irAE registry
Region
| Japan |
Condition
Condition
Advanced non-small-cell lung cancer and advanced gastric cancer which are indications for anti-cytotoxic T-lymphocyte-associated antigen-4, anti-programmed death-1, and anti-programmed death-ligand 1 antibodies.
Classification by specialty
| Gastroenterology | Cardiology | Pneumology |
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The prevalence of cardiovascular immune-related adverse events, including immune-mediated myocarditis, remains unclear because most immunotherapy trials have been conducted without the inclusion of routine cardiac monitoring.
Basic objectives2
Others
Basic objectives -Others
Thus, this registry aims to evaluate the incidence, risk factors, clinical presentation, treatments, and outcomes of both subclinical and clinically evident cardiovascular immune-related adverse events related to immune checkpoint inhibitors. Furthermore, this registry aims to confirm the suitability of regular monitoring for immune-mediated myocarditis using serial electrocardiograms and serum creatine kinase isoenzyme MB (CK-MB), brain natriuretic peptide (BNP), and troponin T in patients receiving immune checkpoint inhibitors. This study intends to assess whether reviewing serial electrocardiograms and serum CK-MB, BNP, and troponin T levels could facilitate the detection of the development of cardiac toxicity before left ventricular dysfunction becomes evident on echocardiography or before the onset of clinical symptoms.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Primary outcomes: Subclinical or smoldering cardiac toxicity, defined as a composite of BNP elevation up to 200 pg/mL, positive troponin T, elevated CK-MB, new-onset morphological electrocardiogram abnormalities, or a reduction in the left ventricular ejection fraction of >10% compared to baseline.
Key secondary outcomes
Secondary outcomes: (1) clinically apparent acute myocarditis; (2) acute heart failure, cardiogenic shock of unknown etiology, or symptomatic deterioration in at least one New York Heart Association functional class; (3) lethal arrhythmia, including advanced or complete AV block, ventricular tachycardia, or fibrillation; (4) cardiac death, new-onset acute coronary syndromes, any coronary revascularization procedure; (5) other immune-related adverse events, including dermatological, ophthalmological, neurological, hematological, gastrointestinal, endocrine, genitourinary, respiratory, and musculoskeletal adverse events; and (6) all-cause death.
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
Patients with advanced non-small-cell lung cancer and advanced gastric cancer which are indications for anti-cytotoxic T-lymphocyte-associated antigen-4, anti-programmed death-1, and anti-programmed death-ligand 1 antibodies.
Key exclusion criteria
Patients who undergo hemodialysis or
have anaphylactic reactions to immune checkpoint inhibitors
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Isawa |
Organization
Sendai Kousei Hospital
Division name
Cardiology
Zip code
980-0873
Address
Hirosemachi 4-15, Sendai, Japan
TEL
022-222-6181
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
Zip code
980-0873
Address
Hirosemachi 4-15, Sendai, Japan
TEL
022-222-6181
Homepage URL
isa_tsuyo@yahoo.co.jp
Sponsor or person
Institute
Frontline Immunotherapy Team, Sendai Kousei Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Sendai Kousei Hospital
Address
Hirosemachi 4-15, Sendai, Japan
Tel
022-2226-1818
heartcenter@st.cat-v.ne.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
Sendai Kousei Hospital (Miyagi prefecture)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://academic.oup.com/oncolo/article/27/5/e410/6555104
Number of participants that the trial has enrolled
129
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 03 | Month | 28 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2018 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 16 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This is a prospective observational study of patients with advanced cancer for the evaluation of checkpoint inhibitor-associated cardiovascular immune-related adverse events.
Management information
Registered date
| 2018 | Year | 05 | Month | 26 | Day |
Last modified on
| 2022 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037322
