NL-OMON44465招募中不适用
Investigating cardiovascular adverse events related to cancer treatment: a study of extreme toxicity using induced pluripotent stem cells - InvestiCAT-iPSC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 48
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 99（—）
入选标准
- •1. any proven cancer treated with curative intent;
- •2. age >= 18 and <= 50 years;
- •3. able to comply with the protocol;
- •4. signed written informed consent.
- •Furthermore, there are specific inclusion criteria for every subject group:
- •[A-TOX]: severe cardiovascular toxicity* during 1 to 3 cycles of anthracyclines (i.e. 60 to 180 mg/m2 doxorubicin or 90 to 270 mg/m2 epirubicin);
- •[A-NO]: >= 3 months after end of cancer treatment which included the maximum tolerable dose of anthracyclines (i.e. 450 to 500 mg/m2 doxorubicin or 850 to 900 mg/m2 epirucibin);
- •[T-TOX]: severe cardiovascular toxicity* within 1 to 6 cycles of trastuzumab (6 mg/kg/3wks or equivalent);
- •[T-NO]: >= 3 months after end of cancer treatment which included a year of trastuzumab (18 cycles of 6 mg/kg/3wks or equivalent).
- •[C-TOX]: severe cardiovascular toxicity* during 1 to 3 cycles of cisplatin (i.e. 100 to 300 mg/m2);
- •[C-NO]: >= 1 year after end of cancer treatment which included high-dose cisplatin (i.e. a cumulative dose of 400 to 1000 mg/m2);
- •[B-TOX]: severe cardiovascular toxicity* during 1 to 3 cycles of bleomycin (i.e. 90 to 270 USP);
- •[B-NO]: >= 1 year after end of cancer treatment which included high-dose bleomycin (i.e. a cumulative dose >= 360 USP);;* Severe cardiovascular toxicity is defined as any of grade 3 - 4 toxicity according to CTCAE 4.03, including but not limited to:
- •* - in the category *Cardiac disorders*:
- •o acute coronary syndrome (symptomatic, unstable angina and/or acute myocardial infarction, cardiac enzymes abnormal, hemodynamically stable - or more severe);
- •o cardiac arrest;
- •o heart failure (severe with symptoms at rest or with minimal activity or exertion; intervention indicated - or more severe)
- •o left ventricular systolic dysfunction (symptomatic due to drop in ejection fraction responsive to intervention - or more severe);
- •o myocardial infarction (severe symptoms; cardiac enzymes abnormal; hemodynamically stable; ECG changes consistent with infarction - or more severe);
- •o restrictive cardiomyopathy (symptomatic heart failure or other cardiac symptoms, responsive to intervention - or more severe);
- •o right ventricular dysfunction (severe symptoms, associated with hypoxemia, right heart failure; oxygen indicated - or more severe);
- •* - in the category *Nervous system disorders*:
- •o stroke (severe neurologic deficit - or more severe);
- •* - in the category *Vascular disorders*:
- •o peripheral ischemia (recurring or prolonged (>= 24 hours) and/or invasive intervention indicated - or more severe);
- •o thromboembolic event (thrombosis (e.g., uncomplicated pulmonary
- •embolism [venous], non-embolic cardiac mural [arterial] thrombus), medical
- •intervention indicated - or more severe);
- •* - in the category *Respiratory, thoracic and mediastinal disorders*:
- •o pneumonitis (severe symptoms; limiting self-care ADL; oxygen indicated - or more severe);
- •o pulmonary fibrosis (severe hypoxemia; evidence of right-sided heart failure; radiographic pulmonary fibrosis > 50 - 75% - or more severe);
- •* - in the category *Renal and urinary disorders*:
- •o acute kidney injury (creatinine > 3 x baseline or > 4.0 mg/dL; hospitalization indicated - or more severe);
- •o chronic kidney disease (estimated Glomerular Filtration Rate or creatinine clearance 29 - 15 ml/min/1.73 m2 - or more severe).
排除标准
- •1. history of cardiovascular disease prior to start of cancer treatment, as evidenced by any of the following:
- •a. symptomatic or treated cardiovascular disease prior to start of cancer treatment;
- •b. LVEF < 55% at any performed MUGA scan or echocardiography prior to start of cancer treatment;
- •2. any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol, or insufficient understanding of the Dutch language;
- •3. any contraindication for skin biopsy, including:
- •a. extensive skin disorder precluding biopsy of unaffected skin;
- •b. known allergy to local anesthetics;
- •4. use of anticoagulants and INR > 3;
- •5. pregnant or lactating female.
- •Furthermore, there are specific exclusion criteria for the *resilient* subject groups [A-NO], [T-NO], [C-NO], and [B-NO]:
- •6. history of cardiovascular disease during or after cancer treatment, as evidenced by any of the following:
- •a. any symptomatic or treated cardiovascular disease;
- •b. LVEF < 55% at any performed MUGA scan or echocardiography.
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