Shizuoka Cardiovascular events Prospective Study

JRCT ID: jRCT1040210102

Registered date:19/11/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Solid tumor
• Date of first enrollment: 22/12/2021
• Target sample size: 200
• Study type: Observational

Outcome(s)

• Primary Outcome: Incidence of cardiac hypofunction

Secondary Outcome

Incidence of cardiac hypofunction by drug
Incidence of cardiac hypofunction by cancer type
Relationship between other patient background and laboratory results at enrollment and incidence of cardiac hypofunction
Incidence of symptomatic cardiac hypofunction
Incidence of other cardiovascular events
Status of treatment for cardiac hypofunction

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients with solid tumor who have received no prior chemotherapy or no more than two regimens of chemotherapy.
2) Anticancer therapy with regimens including immune checkpoint inhibitors or angiogenesis inhibitors (both antibody and tyrosine kinase inhibitors are acceptable) will be started within 28 days of enrollment.
3) At least 20 years old at the time of registration.
4) The treating investigator has determined that anticancer treatment is possible.
5) Survival of at least 24 weeks after enrollment is expected.
6) The patient's written consent to participate in the research has been obtained.

Exclude criteria

1) Patients who are scheduled to receive only local or endocrine therapy as anticancer therapy.
2) Patients scheduled to receive chemoradiation therapy in which the chest area will be irradiated.
3) Patients with a history of treatment with immune checkpoint inhibitors or angiogenesis inhibitors.
4) Patients with acute coronary syndromes (myocardial infarction, angina pectoris), acute heart failure, or other urgent cardiac conditions that require treatment or procedures at the time of enrollment.
5) Patients with obvious cognitive decline or concomitant psychiatric disorders who are judged to be unable to participate in the study.
6) Patients who are judged by the treating investigators to be inappropriate to participate in this study for anti-cancer treatment.

Related Information

• Primary Sponsor: Ko Ryo
• Source(s) of Monetary Support: Shizuoka Cancer Center