Clinical trial NCT04529629: Precise Diagnosis, Treatment and Prognostic Evaluation of Complicated Adrenal Tumor Diseases
Official title: Precise Diagnosis, Treatment and Prognostic Evaluation of Complicated Adrenal Tumor Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Complicated Adrenal Tumor Diseases
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: tumor biochemical marker treatment response
timeFrame: 20 years
measure: Tumor volume assessment: According to RECIST (version 1.1).
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
References: