NL-OMON51479招募中不适用
T-Cell Mediated Plaque Inflammation and Atherosclerosis in Stage III Melanoma Patients on (neo-)adjuvant Immune Checkpoint Inhibitors: a prospective matched cohort study - CHECK-FLAME II
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •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
排除标准
- •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
- •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).
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