Investigating heart-related side effects of cancer immunotherapy
Immune Checkpoint Inhibitor Associated Cardiovascular Adverse Events in Patients With Cancer
This study is testing whether cancer immunotherapy treatments can cause heart problems in patients with certain types of cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 214 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Amsterdam, North Holland) |
| Trial ID | NCT06519292 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the cardiovascular adverse events associated with immune checkpoint inhibitors (ICIs) in cancer patients. It will involve patients diagnosed with specific types of cancer who are starting ICI therapy, focusing on the incidence of arterial thromboembolic events such as myocardial infarction and stroke. Participants will undergo coronary computed tomography angiography (CCTA) at baseline and again after one year to evaluate changes in cardiovascular health. The study seeks to clarify the mechanisms behind the increased cardiovascular risks linked to ICIs.
Who should consider this trial
Good fit: Ideal candidates are patients aged 50 and older with specific types of cancer who are about to start immune checkpoint inhibitor therapy.
Not a fit: Patients who have received immune checkpoint inhibitors in the past 12 months or have certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management strategies for cardiovascular risks in cancer patients receiving immunotherapy.
How similar studies have performed: While there have been retrospective studies indicating increased cardiovascular risks with ICIs, this specific observational approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with confirmed diagnosis of the following tumor types, any stage: esophageal, gastric or junction cancer, colorectal cancer, non-small cell lung carcinoma, melanoma, renal cell carcinoma * Prior to start of new therapy (i.e. immune checkpoint inhibitor, chemotherapy or follow-up in case of esophageal cancer) * Age ≥ 50 years Exclusion Criteria: * ICI therapy in previous 12 months * Suspected or confirmed viral, fungal, or bacterial infectious disease * Use of immunosuppressive therapy prior to ICI start * Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m2 * Known allergy to iodinated contrast agents * Atrial fibrillation
Where this trial is running
Amsterdam, North Holland
- Amsterdam UMC — Amsterdam, North Holland, Netherlands (Recruiting)
Study contacts
- Principal investigator: H.W.M. van Laarhoven, Prof. Dr. — secretariaat.oncologie@amsterdamumc.nl
- Study coordinator: A Strijdhorst
- Email: a.strijdhorst@amsterdamumc.nl
- Phone: +31 205665975
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.