The Prevalence and Characteristics of Adrenal Incidentaloma

Adrenal Incidentaloma Clinical Trial

Official title:

The Prevalence and Characteristics of Adrenal Incidentaloma: A Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04682938
• Other study ID #: AI-China2020
• Status: Completed
• Start date: November 20, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: August 2022
• Source: Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To investige the prevalence, characteristics and prognosis of adrenal incidentalomas 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. Most AI are benign and do not have the function of autonomic hormone secretion, but about 20% of them have function and can secrete adrenal hormone autonomously. Studies based on biopsy reports show that the prevalence of AI is about 2%, and the prevalence of AI detected by CT scan is 1% - 4.5%. However, most of these studies are retrospective, and there may be selection bias and other confounding factors. There is no large sample prospective study on the prevalence of AI in the general population. The purpose of this study is to prospectively include patients with adrenal incidentaloma in community physical examination population, and evaluate their function and prognosis. The research results will provide new evidence for standardized diagnosis and treatment of adrenal incidentaloma in the future.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25356
• Est. completion date: November 30, 2021
• Est. primary completion date: November 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 78 Years

Eligibility

Inclusion Criteria:

·On weekdays, the first 100 individuals, aged 18 to 78 years, taking health checkup in the Community Health Examination Center were invited to take part in the study.

Exclusion Criteria:

• with known adrenal diseases;
• with continuous steroids or drug treatment that might influence cortisol secretion ordexamethasone metabolism and could not be stopped
• refuse to participate in the study.

Related Conditions & MeSH terms

• Adrenal Gland Neoplasms
• Adrenal Incidentaloma
• Adrenocortical Adenoma
• Prevalence

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Chongqing Medical University, Chongqing, China	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing Medical University

Country where clinical trial is conducted

China, 

References & Publications (3)

Fassnacht M, Arlt W, Bancos I, Dralle H, Newell-Price J, Sahdev A, Tabarin A, Terzolo M, Tsagarakis S, Dekkers OM. Management of adrenal incidentalomas: European Society of Endocrinology Clinical Practice Guideline in collaboration with the European Netwo — View Citation

Ichijo T, Ueshiba H, Nawata H, Yanase T. A nationwide survey of adrenal incidentalomas in Japan: the first report of clinical and epidemiological features. Endocr J. 2020 Feb 28;67(2):141-152. doi: 10.1507/endocrj.EJ18-0486. Epub 2019 Nov 7. — View Citation

Lee JM, Kim MK, Ko SH, Koh JM, Kim BY, Kim SW, Kim SK, Kim HJ, Ryu OH, Park J, Lim JS, Kim SY, Shong YK, Yoo SJ; Korean Endocrine Society, Committee for Clinical Practice Guidelines. Clinical Guidelines for the Management of Adrenal Incidentaloma. Endocri — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence and Characteristics of Adrenal Incidentaloma	To investigate the prevalence and characteristics of Adrenal Incidentaloma in general population in China	1 years
Secondary	Steroid hormones in the function of Adrenal Incidentaloma	prospectively evaluate potential predictive role of combined detection of multiple steroid hormones in the function of Adrenal Incidentaloma	1 years