Investigating heart-related side effects of cancer immunotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.