Cohort Study of Adrenogenic Autonomic Cortisol Secretion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Diagnosis, Treatment, Adrenogenic Autonomic Cortisol Secretion. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
To investige the etiology, pathogenesis, diagnosis and treatment of adrenogenic autonomic cortisol secretion in Chinese adults.
Detailed description
With the development of imaging detection technology and its wide application in clinic, the detection rate of adrenal incidentaloma (AI) has been greatly improved. In our previous study, 18.9% of AI were accompanied by autonomic cortisol secretion (ACS) in Chinese. The vast majority of ACS is mild (MACS). Due to the lack of typical Cushing manifestations and the low rate of progression to overt Cushing, MACS has received insufficient attention in the past. However, recent studies have found that MACS have a higher incidence of diabetes, hypertension, cardiovascular events, metabolic bone disease and mortality risk than those with non-functional adenomas. With appropriate treatment, the complications of MACS patients can be effectively improved. However, personalized treatment of MACS is a clinical difficulty. It is hard to determine whether the cortisol secretion of patients is caused by AI or whether patients will benifit from operation. There are some retrospective studies have provided some evidence, while prospective studies are lacking. The purpose of this study is to prospectively include patients with autonomic cortisol secretion, evaluate function and diagnosis, develop personalized treatment strategy, and follow up the prognosis. The research results will provide new evidence for standardized diagnosis and treatment of adrenogenic autonomic cortisol secretion in the future.
Primary outcome measures
- SUVmax value of PET-CT [Time frame: 10 years]
Secondary outcome measures (1)
- Etiology and pathogenesis of adrenogenic autonomic cortisol secretion [Time frame: 10 years]
Eligibility criteria
Inclusion criteria
- CT examination revealed adrenal nodules (maximum diameter ≥10mm);
- Serum cortisol > 50nmol/L after 1mg dexamethasone inhibition test (1mg-DST).
Exclusion criteria
- Patients with primary aldosteronism (PA), pheochromocytoma, adrenal metastatic carcinoma, congenital adrenal hyperplasia (CAH), ganglionic neuroma/paraganglioma, schwannoma, adrenal hematoma and those with no definite diagnosis were evaluated by clinical and endocrine function.
- Patients with serious underlying diseases (such as liver and kidney failure, acute severe infection, etc.) that may affect the function of the hypothalamic-pituitary-adrenal axis (HPA axis); Pregnancy.
- Patients with a history of alcoholism, fatigue, trauma, infection, depression, glucocorticoid use, and other drugs affecting the function of the hypothalamic-pituitary-adrenal axis.
- Patients who are not willing to participate in and complete this study refuse to sign the written informed consent for this study.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Jing Y, Hu J, Luo R, Mao Y, Luo Z, Zhang M, Yang J, Song Y, Feng Z, Wang Z, Cheng Q, Ma L, Yang Y, Zhong L, Du Z, Wang Y, Luo T, He W, Sun Y, Lv F, Li Q, Yang S. Prevalence and Characteristics of Adrenal Tumors in an Unselected Screening Population : A Cross-Sectional Study. Ann Intern Med. 2022 Oct;175(10):1383-1391. doi: 10.7326/M22-1619. Epub 2022 Sep 13. PMID 36095315
- Prete A, Subramanian A, Bancos I, Chortis V, Tsagarakis S, Lang K, Macech M, Delivanis DA, Pupovac ID, Reimondo G, Marina LV, Deutschbein T, Balomenaki M, O'Reilly MW, Gilligan LC, Jenkinson C, Bednarczuk T, Zhang CD, Dusek T, Diamantopoulos A, Asia M, Kondracka A, Li D, Masjkur JR, Quinkler M, Ueland GA, Dennedy MC, Beuschlein F, Tabarin A, Fassnacht M, Ivovic M, Terzolo M, Kastelan D, Young WF J PMID 34978855
- Deutschbein T, Reimondo G, Di Dalmazi G, Bancos I, Patrova J, Vassiliadi DA, Nekic AB, Debono M, Lardo P, Ceccato F, Petramala L, Prete A, Chiodini I, Ivovic M, Pazaitou-Panayiotou K, Alexandraki KI, Hanzu FA, Loli P, Yener S, Langton K, Spyroglou A, Kocjan T, Zacharieva S, Valdes N, Ambroziak U, Suzuki M, Detomas M, Puglisi S, Tucci L, Delivanis DA, Margaritopoulos D, Dusek T, Maggio R, Scaroni C PMID 35533704
Identifiers
NCT: NCT05743933 · AC-China 2023