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临床试验/NCT05743933
NCT05743933招募中不适用

Chongqing Adrenogenic Autonomic Cortisol Secretion Cohort Study

Chongqing Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2023年2月17日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
SUVmax value of PET-CT

研究概览

简要总结

To investige the etiology, pathogenesis, diagnosis and treatment of adrenogenic autonomic cortisol secretion in Chinese adults.

详细描述

With the development of imaging detection technology and its wide application in clinic, the detection rate of adrenal incidentaloma (AI) has been greatly improved. In our previous study, 18.9% of AI were accompanied by autonomic cortisol secretion (ACS) in Chinese. The vast majority of ACS is mild (MACS). Due to the lack of typical Cushing manifestations and the low rate of progression to overt Cushing, MACS has received insufficient attention in the past. However, recent studies have found that MACS have a higher incidence of diabetes, hypertension, cardiovascular events, metabolic bone disease and mortality risk than those with non-functional adenomas. With appropriate treatment, the complications of MACS patients can be effectively improved. However, personalized treatment of MACS is a clinical difficulty. It is hard to determine whether the cortisol secretion of patients is caused by AI or whether patients will benifit from operation. There are some retrospective studies have provided some evidence, while prospective studies are lacking. The purpose of this study is to prospectively include patients with autonomic cortisol secretion, evaluate function and diagnosis, develop personalized treatment strategy, and follow up the prognosis. The research results will provide new evidence for standardized diagnosis and treatment of adrenogenic autonomic cortisol secretion in the future.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •CT examination revealed adrenal nodules (maximum diameter ≥10mm);
  • •Serum cortisol > 50nmol/L after 1mg dexamethasone inhibition test (1mg-DST).

排除标准

  • •Patients with primary aldosteronism (PA), pheochromocytoma, adrenal metastatic carcinoma, congenital adrenal hyperplasia (CAH), ganglionic neuroma/paraganglioma, schwannoma, adrenal hematoma and those with no definite diagnosis were evaluated by clinical and endocrine function.
  • •Patients with serious underlying diseases (such as liver and kidney failure, acute severe infection, etc.) that may affect the function of the hypothalamic-pituitary-adrenal axis (HPA axis); Pregnancy.
  • •Patients with a history of alcoholism, fatigue, trauma, infection, depression, glucocorticoid use, and other drugs affecting the function of the hypothalamic-pituitary-adrenal axis.
  • •Patients who are not willing to participate in and complete this study refuse to sign the written informed consent for this study.

研究组 & 干预措施

Study group

Accidental adrenal tumor with 1mg-DST cortisol >50nmol/L

Control group

Accidental adrenal tumor with 1mg-DST cortisol ≤50nmol/L

结局指标

主要结局

SUVmax value of PET-CT

时间窗: 10 years

To explore the value of 68\[Ga\]-Pentixafor PET-CT in the diagnosis of MACS

次要结局

  • Etiology and pathogenesis of adrenogenic autonomic cortisol secretion(10 years)

研究者

发起方
Chongqing Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Qifu Li

Prof.

Chongqing Medical University

研究点 (1)

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