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NCT Number: NCT05743933

Cohort Study of Adrenogenic Autonomic Cortisol Secretion

To investige the etiology, pathogenesis, diagnosis and treatment of adrenogenic autonomic cortisol secretion in Chinese adults.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. SUVmax value of PET-CT

    Time frame: 10 years

    To explore the value of 68[Ga]-Pentixafor PET-CT in the diagnosis of MACS

Secondary outcomes

  1. Etiology and pathogenesis of adrenogenic autonomic cortisol secretion

    Time frame: 10 years

    To study the etiology and pathogenesis of adrenogenic autonomic cortisol secretion

Study contacts

Contact information is provided by the study sponsor or research team.

Qifu Li, PhD

CONTACT

[email protected]

+86-023-89011552

Shumin Yang, PhD

CONTACT

[email protected]

+86-023-89011552

Sponsors and collaborators

Lead sponsor

Chongqing Medical University

Other

Registry information

Important dates

Study start
2023
Primary completion
2033
Study completion
2033
First posted
Feb 24, 2023
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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