Extensive CArdioVAscular Characterization and Follow-up of Patients Receiving Immune Checkpoint Inhibitors
Reason given: Study was stopped due to negative preliminary analysis, slow recruitment (105 patients over 2,5 years), lack of funding, need for more centers, and the changing treatment landscape (approval of ICIs in combination with other cancer treatments).
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Trial details
- Who runs it
- Algemeen Ziekenhuis Maria Middelares
- Trial code
- NCT05699915
- Record updated
- 30 January 2025
- Original description
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).Read full original descriptionShow less
Extensive CArdioVAscular Characterization and Follow-up of Patients Receiving Immune Checkpoint Inhibitors: a Prospective Multicentre Study
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 investigate troponin and NT-proBNP values in patients receiving ICIs and their association with ICI-induced CV abnormalities and MACEs. * Study the calcium score, systolic, and diastolic (dys)function. * Evaluate associations between patient/disease characteristics / transthoracic echocardiography parameters / electrocardiography parameters and troponin / NT-proBNP levels.
Participants 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: 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) therapy; Be literate in Dutch or English.
Exclusion: Prior treatment with immunotherapy (immune checkpoint inhibitors, T-cell transfer therapy, cancer treatment vaccines or immune system modulators); Having a diagnosis of immunodeficiency or is receiving chronic/active systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent); Patients who will receive ICIs in combination with an additional systemic anti-cancer 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.