Precise Diagnosis, Treatment and Prognostic Evaluation of Complicated Adrenal Tumor Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- tumor biochemical marker treatment response
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients with renal insufficiency (Cr>2 times the upper limit of normal).
- •Patients with a history of liver cirrhosis.
- •Patients who are currently using corticosteroids.
- •Patients with cardiac insufficiency (NYHA cardiac function classification grade 3 and above or EF<50%).
- •Patients with stroke and acute myocardial infarction in the past 6 months.
- •Patients during pregnancy and lactation
结局指标
主要结局
tumor biochemical marker treatment response
时间窗: 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%).
Tumor volume assessment: According to RECIST (version 1.1).
时间窗: 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.
次要结局
未报告次要终点
研究者
Wang Weiqing
PhD, MD
Shanghai Jiao Tong University School of Medicine
