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Precise Diagnosis, Treatment and Prognostic Evaluation of Complicated Adrenal Tumor Diseases

2021年12月17日 更新者:Wang Weiqing、Shanghai Jiao Tong University School of Medicine

The adrenal gland is an important organ that produces life hormones. There are many types of adrenal tumors, which tend to occur in young adults and affect the whole body. It has the dual threat: hormone secretion and tumor metastasis. At present, there are four major dilemmas in the clinical diagnosis and treatment of adrenal tumors: 1) Pulse secretion of the hormones, which are affected by many factors; and the diagnostic value of single hormone is limited; 2) Traditional imaging cannot accurately reflect the characteristics of hormone secretion. The prognosis cannot be accurately predicted; 3) The molecular characteristics of tumor cells and the microenvironment are unclear, making it difficult to implement early diagnosis and precise treatment; 4) Traditional pathology cannot determine the nature and long-term prognosis of the tumor, which makes the treatment delay, and the disease prognosis is extremely poor. It threatens the lives of patients.

Starting from solving the above-mentioned key problems in the early stage, the research team has systematically established new clinical diagnostic technologies, hormone dynamic tests to accurately assess hormone secretion and segmented blood collection hormone determination technologies to accurately locate adrenal tumors; A series of important research results have been published in Science, Lancet Diabetes & Endocrinology, Cell Research, etc To sum up, the goal of this research is improving the early diagnosis rate of complicated adrenal tumors especially in malignant tumors, developing the optimal treatment plan, avoiding unnecessary surgical treatment, improving the quality of life of patients, reducing mortality. This project will further integrate the adrenal cortex and medulla hormone mass spectrometry detection and the molecular markers of adrenal tumors through phenotypic, functional imaging, and molecular pathological evaluations, and built a sensitive drug screening platform that integrates visual drug response and molecular characteristics, thereby achieving precise diagnosis and treatment of complicated adrenal tumors.

研究概览

研究类型

观察性的

注册 (预期的)

1000

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

  • 姓名:Luming Wu, PhD
  • 电话号码:8621-64370045
  • 邮箱wulum@126.com

学习地点

    • Shanghai
      • Shanghai、Shanghai、中国、200025
        • 招聘中
        • Ruijin Hospital
        • 接触:
          • Yiran Jiang

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Inclusion Criteria:

  • Age ≥ 18 years old and ≤ 75 years
  • Diagnosis of Patients with primary aldosteronism, pheochromocytoma, and cortical cancer
  • Gender: males and females
  • Provide written informed consent
  • Satisfactory compliance

Exclusion Criteria:

  1. Patients with renal insufficiency (Cr>2 times the upper limit of normal).
  2. Patients with a history of liver cirrhosis.
  3. Patients who are currently using corticosteroids.
  4. Patients with cardiac insufficiency (NYHA cardiac function classification grade 3 and above or EF<50%).
  5. Patients with stroke and acute myocardial infarction in the past 6 months.
  6. Patients during pregnancy and lactation

描述

Inclusion Criteria:

  • Age ≥ 18 years old and ≤ 75 years
  • Diagnosis of Patients with primary aldosteronism, pheochromocytoma, and cortical cancer
  • Gender: males and females
  • Provide written informed consent
  • Satisfactory compliance

Exclusion Criteria:

  1. Patients with renal insufficiency (Cr>2 times the upper limit of normal).
  2. Patients with a history of liver cirrhosis.
  3. Patients who are currently using corticosteroids.
  4. Patients with cardiac insufficiency (NYHA cardiac function classification grade 3 and above or EF<50%).
  5. Patients with stroke and acute myocardial infarction in the past 6 months.
  6. Patients during pregnancy and lactation

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
primary aldosteronism
pheochromocytoma and adrenocortical carcinoma need surgery and primary aldosteronism need drug according to the genetic results
pheochromocytoma
pheochromocytoma and adrenocortical carcinoma need surgery and primary aldosteronism need drug according to the genetic results
adrenocortical carcinoma
pheochromocytoma and adrenocortical carcinoma need surgery and primary aldosteronism need drug according to the genetic results

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
tumor biochemical marker treatment response
大体时间:20 years
  • Complete remission (normalization of tumor markers);

    • Partial remission (reduction of tumor markers ≥ 50%); ③No change (decrease of tumor markers <50% or increase ≤25%); ④Disease progression (tumor markers increased> 25%).
20 years
Tumor volume assessment: According to RECIST (version 1.1).
大体时间:20 years
  • Complete response: All target lesions disappear, and the short axis of any pathological lymph nodes must be reduced to <10 mm.

    • Partial Response: The total diameter of the target lesions is reduced by at least 30% compared with the baseline.

      • Progressive Disease: Take the minimum value of the sum of the diameters of all target lesions measured during the study as the reference, and the relative increase in diameter sum by at least 20% ④Stable Disease: Based on the minimum value of the sum of the diameters of all target lesions measured during the study, the reduction of the target lesion did not reach PR, and the degree of increase did not reach PD, between PR and PD.
20 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年8月30日

初级完成 (预期的)

2040年8月30日

研究完成 (预期的)

2041年8月30日

研究注册日期

首次提交

2020年8月24日

首先提交符合 QC 标准的

2020年8月24日

首次发布 (实际的)

2020年8月27日

研究记录更新

最后更新发布 (实际的)

2021年12月27日

上次提交的符合 QC 标准的更新

2021年12月17日

最后验证

2021年12月1日

更多信息

与本研究相关的术语

其他研究编号

  • CCEMD-2020-0825

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

surgery or drug的临床试验

3
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