Extensive CArdioVAscular Characterization and Follow-up of Patients Receiving Immune Checkpoint Inhibitors

The goal of this prospective, multicentre study is to investigate short- and long-term cardiovascular effects in cancer patients treated with immune checkpoint inhibitors (ICIs).The main question[s] it aims to answer are:To evaluate cardiac markers and their possible relationship with cardiac abnormalitiesTo estimate the incidence of cardiac adverse events of ICIs in a real world populationTo predict and detect cardiac abnormalities in an earlier (subclinical) stageTo investigate possible progression of coronary atherosclerosisParticipants will be closely monitored by performing the following additional visits and testing:Chest CT scan prior to treatment start, after 12 and 24 months.Consultation with a cardiologist at baseline, 3, 6, 12 and 24 months, who will perform an electrocardiogram and echocardiogram.One additional blood sample prior to treatment start, after 3, 6, 12 and 24 months. An extra blood sample could be taken in case of sudden heart problems.Non-invasive endothelial function tests prior to treatment start, after 12 and 24 months.

Inclusion Criteria:Have a solid tumour and will receive one of the following therapies based on current evidence based clinical guidelines: anti-programmed cell death protein-1 (PD-1), anti-programmed cell death ligand-1 (PD-L1) and/or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) therapyBe literate in Dutch or EnglishExclusion Criteria:Prior treatment with immunotherapy (immune checkpoint inhibitors, T-cell transfer therapy, cancer treatment vaccines or immune system modulators).Patients who will receive ICIs in combination with an additional regimen (chemotherapy, tyrosine kinase inhibitors,…).Having a known history of human immunodeficiency virus (HIV) infection.Having a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or known active hepatitis C virus (defined as detectable RNA via qualitative nucleic acid testing) infection.Having a diagnosis of immunodeficiency or is receiving chronic/active systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent)