UMIN-ICDS 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

Email

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


Email

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

Email

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/icdr_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