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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04529629
Recruitment Status : Not yet recruiting
First Posted : August 27, 2020
Last Update Posted : August 27, 2020
Sponsor:
Information provided by (Responsible Party):
Wang Weiqing, Shanghai Jiao Tong University School of Medicine

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.


Condition or disease Intervention/treatment
Complicated Adrenal Tumor Diseases Other: surgery or drug

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Precise Diagnosis, Treatment and Prognostic Evaluation of Complicated Adrenal Tumor Diseases
Estimated Study Start Date : August 30, 2020
Estimated Primary Completion Date : August 30, 2040
Estimated Study Completion Date : August 30, 2041

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. tumor biochemical marker treatment response [ Time Frame: 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%).

  2. Tumor volume assessment: According to RECIST (version 1.1). [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
DNA, Serum, plasma and full blood samples are retained


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04529629


Contacts
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Contact: Yiran Jiang, MD 8621-64370045 rainy0409@hotmail.com
Contact: Luming Wu, PhD 8621-64370045 wulum@126.com

Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
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Responsible Party: Wang Weiqing, PhD, MD, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT04529629    
Other Study ID Numbers: CCEMD-2020-0825
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Adrenal Gland Diseases
Endocrine System Diseases