Reporting, Evaluating, Preventing and Treating the Cardiotoxicity Induced by Anticancer Drugs During a Specific Cardio-oncology Consult and Follow up in Routine Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 6
- 主要终点
- Number of patients having a benefit after this specific cardio-oncology check up and follow up
研究概览
简要总结
Several Drugs used in routine care in oncology induce rare but often severe or fatal cardiovascular or metabolic side effects. This study will investigate, evaluate, report and treat the cardiovascular side effects of anticancer drugs, through a specific cardiovascular routine checkup and follow-up taking place in several Cardio-oncology programs throughout France. The different including centers will be: Assistance Publique - Hôpitaux de Paris (APHP.6: Pitié-Salpétrière, Saint Antoine and Tenon's hospitals, Paris, France).
详细描述
Several anticancer and supportive care drugs used in oncology have an impact on the cardiovascular and metabolic systems, leading to a wide range of cardiovascular and metabolic disorders and side effects. Those are poorly described, due to the evolution of the anticancer pharmacopeia, and recent recognition of these adverse events. This study will investigate the potential benefits of a specialized cardio-oncology check-up and follow-up in this context.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suffering a cancer
- •Evaluated within a cardio-oncology program
排除标准
- 未提供
结局指标
主要结局
Number of patients having a benefit after this specific cardio-oncology check up and follow up
时间窗: 5 years
次要结局
- All relevants statistical associations between cardiovascular side effects induced by oncology treatments , and other potentials kind of side effects induced by oncology treatments(5 years)
- All relevants statistical associations between metabolic side effects induced by oncology treatments , and other potentials kind of side effects induced by oncology treatments(5 years)
- All relevant statistical associations between duration and type of treatement used to manage metabolic side effects induced by oncology treatments, and overall survival(5 years)
- All relevants staisticals associations between adverse events and anticancer drugs(5 years)
- All relevant statistical associations between duration and type of treatement used to manage cardiovascular side effects induced by oncology treatments, and overall survival(5 years)
- All relevants statistical associations between differential features of subgroups of patients, and the occurence of metabloic side effects induced by oncology treatments(5 years)
- All relevant statistical associations between new therapies to treat or prevent the metabolic side effects induced by oncology treatments, and overall survival(5 years)
- All relevant statistical associations between the pre therapeutic metabolic checkup and follow up for patients with cancer or history of cancer, and the occurence of metabolic toxicities of oncology treatments.(5 years)
- Evaluating the overall survival of patients suffering from cardiovascular or metabolic side effect of oncology treatments(5 years)
- All relevants statistical associations between differential features of subgroups of patients, and the occurence of cardiovascular side effects induced by oncology treatments(5 years)
- All relevant statistical associations between the pre therapeutic cardiovascular checkup and follow up for patients with cancer or history of cancer, and the occurence of cardiovascular toxicities of oncology treatments.(5 years)
- All relevant statistical associations between cardiovascular toxicities, and anticancer drugs(5 years)
- All relevant statistical associations between new therapies to treat or prevent the cardiovascular side effects induced by oncology treatments, and overall survival(5 years)
- All relevant statistical associations between metabolic toxicities, and anticancer drugs(5 years)
研究者
Joe Elie Salem
Assistant director, clinical investigation center Paris Est
Groupe Hospitalier Pitie-Salpetriere