跳至主要内容
临床试验/NCT04079647
NCT04079647招募中不适用

Immune Checkpoint Inhibitor Therapy- Induced Endocrinopathy and Metabolic Diseases -a Case Series of Taiwanese Patients

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年7月3日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
200
试验地点
1
主要终点
Changes of endocrine profiles

研究概览

简要总结

To review cases from NTUH who developed endocrinopathy and metabolic diseases after immunotherapy, and statistically analyzed their age, clinical presentation, image findings, treatment and its response.

详细描述

Immune checkpoint blockade-based immunotherapy is a new modality of cancer treatment with a unique mechanism that has gained increased numbers of indication and is now used in several cancer types. However, immune-related adverse events (irAEs) emerge as a new entity of diseases involving one or multiple organ systems. irAEs could result in interruption of immunotherapy, morbidities of patients or even death. Among various manifestations of irAEs, endocrinopathy and metabolic diseases are rare but important, and require prompt diagnosis and treatment to avoid life-threatening conditions.

Thus, we intend to review cases from NTUH who developed endocrinopathy and metabolic diseases after immunotherapy, and statistically analyzed their age, clinical presentation, image findings, treatment and its response. We will also review literatures to evaluate the difference and similarity from previous diagnostic and treatment experience.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who receive immunotherapy in NTUH and develop endocrinopathy after therapy

排除标准

  • Patients less than 20 years old. Patients who are pregnant

研究组 & 干预措施

Patient with endocrinopathy after immunotherapy

Patient with endocrinopathy after immunotherapy

干预措施: Immunotherapy (Drug)

结局指标

主要结局

Changes of endocrine profiles

时间窗: 10 year

Changes of serum fT4 TSH Glucose A1C ACTH cortisol LH FSH estradiol progesterone GH IGF1 prolactin

次要结局

  • Treatment response of the cancer after immunotherapy(10 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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