- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04529629
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studiekontakt
- Namn: Yiran Jiang, MD
- Telefonnummer: 8621-64370045
- E-post: rainy0409@hotmail.com
Studera Kontakt Backup
- Namn: Luming Wu, PhD
- Telefonnummer: 8621-64370045
- E-post: wulum@126.com
Studieorter
-
-
Shanghai
-
Shanghai, Shanghai, Kina, 200025
- Rekrytering
- Ruijin Hospital
-
Kontakt:
- Yiran Jiang
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
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:
- 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
Beskrivning
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:
- 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
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
tumor biochemical marker treatment response
Tidsram: 20 years
|
|
20 years
|
Tumor volume assessment: According to RECIST (version 1.1).
Tidsram: 20 years
|
|
20 years
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CCEMD-2020-0825
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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