T-Cell Mediated Plaque Inflammation and Atherosclerosis in Stage III Melanoma Patients on (neo-)adjuvant Immune Checkpoint Inhibitors: a prospective matched cohort study
- Conditions
- skin cancermelanoma100409001000321610082206
- Registration Number
- NL-OMON51479
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
Exposure group:
• The patient has a diagnosis of melanoma stage III.
• The patient is scheduled to be treated with (neo-)adjuvant ICI immunotherapy.
• The patient is 18 years or older.
• The patient has given written informed consent.
Control group:
• The patient has a diagnosis of melanoma stage IB or II.
• The patient will not be treated with ICI immunotherapy.
• The patient is 18 years or older.
• The patient has given written informed consent.
• If possible: the patient uses cholesterol-lowering drugs in the case that
statins are initiated after baseline CCTA scan for a patient in the exposure
group to whom the patient can be matched
The patient is unable to give informed consent.
The patient suffers from severe psychiatric disorder.
The patient has a history of cardiovascular disease.
The patient has a contra-indication for a PET or CT-scan. If female and
fertile: signs and symptoms of pregnancy or a positive pregnancy test /
breast-feeding, (severe) claustrophobia. Low dose benzodiazepines are allowed.
The patients uses cholesterol-lowering-drugs before baseline scans (only
exposure group).
The patients actively uses or is scheduled to use > 10 mg prednisolone per day
and/or treatment with an equivalent dose of other systemic corticosteroids.
The patient has uncontrolled diabetes/elevated blood glucose levels (>11.1
mmol/L). The use of short-acting insulins within 4 hours of the PET scan is not
allowed
The patient is unable to understand, or unlikely to comply with, the study
requirements.
The patient does not wish to be informed of incidental findings (e.g. cancer
metastasis or other disease).
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoints of the study are:<br /><br>- The absolute and relative change in 18F-FDG uptake in prespecified arterial<br /><br>segments defined by maximum target-to-background-ratio (TBRmax) between<br /><br>baseline, 6 months (exposure group only) and 18 months (PET-CT).<br /><br>- The absolute and relative change of total plaque volume in respectively mm3<br /><br>and % in the coronary arteries between baseline and 18 months in the exposure<br /><br>group (CCTA).</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoints will be:<br /><br>- Incidence of major adverse cardiac events at follow up: Acute coronary<br /><br>syndrome (ACS), Ischemic stroke, Cardiac death, Peripheral arterial disease<br /><br>requiring interventional treatment<br /><br>- The change plaque composition and in the coronary arteries determined by<br /><br>Hounsfield units (HU) between baseline and after 18 months in the exposure<br /><br>group.<br /><br>- The change between baseline and after 18 months in the levels of biochemical<br /><br>markers of inflammation and atherosclerosis (e.g. GDF 15, PCT, OPN, Copeptin,<br /><br>ET-1, MPO, Ang-2, Relaxin-1, NT-proBNP, Troponine-T)</p><br>