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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000032729
Receipt No. 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 2018/05/28

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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
Middle name
Last name Isawa Tsuyoshi
Organization Sendai Kousei Hospital
Division name Cardiology
Zip code
Address Hirosemachi 4-15, Sendai, Japan
TEL 022-222-6181
Email isa_tsuyo@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Isawa Tsuyoshi
Organization Sendai Kousei Hospital
Division name Cardiology
Zip code
Address Hirosemachi 4-15, Sendai, Japan
TEL 022-222-6181
Homepage URL
Email isa_tsuyo@yahoo.co.jp

Sponsor
Institute Frontline Immunotherapy Team, Sendai Kousei Hospital
Institute
Department

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
Address
Tel
Email

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 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 Open public recruiting
Date of protocol fixation
2018 Year 05 Month 16 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 16 Day
Last follow-up date
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
2018 Year 05 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037322

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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