NCT06851702招募中不适用
Observational Study for the Evaluation of Immune-mediated Endocrinological Adverse Events in Patients with Hematological Malignancies and Subjected to Treatment with Immune-checkpoint Inhibitors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Evaluate the incidence, type and severity of immune-related endocrine side effects
研究概览
简要总结
Retrospective / prospective observational study of endocrinological adverse events in hematologic patients treated with immunological checkpoint inhibitors
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Retrospective cohort
- •patients aged> 18 years
- •cyto-histological diagnosis of mature lymphoproliferative syndrome of B or T lymphocyte origin
- •advanced stage of illness (relapsed or refractory)
- •patients undergoing treatment with immune anticheckpoint antibodies.
- •written informed consent
- •Prospective cohort
- •patients aged> 18 years
- •cyto-histological diagnosis of mature lymphoproliferative syndrome of B or T lymphocyte origin
- •advanced stage of illness (relapsed or refractory)
- •patients who are candidates for therapy with anticheckpoint immune antibodies (it is specified that this therapy is completely independent of the subject's participation in the study).
- •written informed consent
排除标准
- •Severe, acute and chronic medical or psychiatric disorders that may affect the interpretation of the study results or interfere with it.
结局指标
主要结局
Evaluate the incidence, type and severity of immune-related endocrine side effects
时间窗: through study completion, an average of 2 years
to evaluate the incidence, type and severity of immune-related endocrine side effects (thyroid disease, hypophysitis, diabetes) in patients treated with ICIs, through haematological-endocrinological management.
次要结局
- search for predictive criteria for the appearance of immune-mediated endocrine toxicities(through study completion, an average of 2 year)
- impact of toxicity on the continuation of therapy(through study completion, an average of 2 year)
- monitoring system for early diagnosis and management of toxicities(through study completion, an average of 2 year)
研究者
研究点 (1)
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