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

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.

Study Overview

• Status: Recruiting
• Conditions: Complicated Adrenal Tumor Diseases
• Intervention / Treatment: Other: surgery or drug

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Yiran Jiang, MD; Phone Number: 8621-64370045; Email: rainy0409@hotmail.com
• Study Contact Backup: Name: Luming Wu, PhD; Phone Number: 8621-64370045; Email: wulum@126.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital
      • Contact: Yiran Jiang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
primary aldosteronism	Other: surgery or drug; pheochromocytoma and adrenocortical carcinoma need surgery and primary aldosteronism need drug according to the genetic results
pheochromocytoma	Other: surgery or drug; pheochromocytoma and adrenocortical carcinoma need surgery and primary aldosteronism need drug according to the genetic results
adrenocortical carcinoma	Other: surgery or drug; pheochromocytoma and adrenocortical carcinoma need surgery and primary aldosteronism need drug according to the genetic results

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tumor biochemical marker treatment response	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).	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

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2021
• Primary Completion (Anticipated): August 30, 2040
• Study Completion (Anticipated): August 30, 2041

Study Registration Dates

• First Submitted: August 24, 2020
• First Submitted That Met QC Criteria: August 24, 2020
• First Posted (Actual): August 27, 2020

Study Record Updates

• Last Update Posted (Actual): December 27, 2021
• Last Update Submitted That Met QC Criteria: December 17, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Adrenal Gland Diseases; Adrenal Gland Neoplasms
• Other Study ID Numbers: CCEMD-2020-0825

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No