Cohort Study of Adrenogenic Autonomic Cortisol Secretion

Treatment Clinical Trial

Official title:

Cohort Study of Adrenogenic Autonomic Cortisol Secretion

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05743933
• Other study ID #: AC-China 2023
• Status: Not yet recruiting
• Start date: February 17, 2023
• Est. completion date: February 15, 2033

Study information

• Verified date: February 2023
• Source: Chongqing Medical University
• Contact: Qifu Li, PhD
• Phone: +86-023-89011552
• Email: liqifu[@]yeah.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: February 15, 2033
• Est. primary completion date: February 15, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diagnosis
• Disease
• Treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

References & Publications (3)

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, Kocj — View Citation

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 Cr — View Citation

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, Ko — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SUVmax value of PET-CT	To explore the value of 68[Ga]-Pentixafor PET-CT in the diagnosis of MACS	10 years
Secondary	Etiology and pathogenesis of adrenogenic autonomic cortisol secretion	To study the etiology and pathogenesis of adrenogenic autonomic cortisol secretion	10 years