Clinical trial NCT05743933: Cohort Study of Adrenogenic Autonomic Cortisol Secretion
Official title: Cohort Study of Adrenogenic Autonomic Cortisol Secretion
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diagnosis
Treatment
Adrenogenic Autonomic Cortisol Secretion
Keywords: Diagnosis and differential diagnosis
Treatment and prognosis
Adrenogenic Autonomic Cortisol Secretion
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2023-02-24
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with adrenal incidentaloma and serum cortisol \> 50nmol/L after 1mg dexamethasone inhibition test, without other situation mentioned in exclusion criteria.

Brief summary: 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.

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.

Primary outcomes:
measure: SUVmax value of PET-CT
timeFrame: 10 years
Secondary outcomes:
measure: Etiology and pathogenesis of adrenogenic autonomic cortisol secretion
timeFrame: 10 years
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Qifu Li, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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