Clinical trial NCT04682938: The Prevalence and Characteristics of Adrenal Incidentaloma
Official title: The Prevalence and Characteristics of Adrenal Incidentaloma: A Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prevalence
Adrenal Incidentaloma
Keywords: Prevalence
characteristics
adrenal incidentaloma
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 25356
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese community adults

Brief summary: To investige the prevalence, characteristics and prognosis of adrenal incidentalomas 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prevalence and Characteristics of Adrenal Incidentaloma
timeFrame: 1 years
Secondary outcomes:
measure: Steroid hormones in the function of Adrenal Incidentaloma
timeFrame: 1 years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: the First Affiliated Hospital of Chongqing Medical University, Chongqing, China
state: Chongqing
Study officials:
affiliation: First Affiliated Hospital of Chongqing Medical University
name: Li Qifu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. Endocrinol Metab (Seoul). 2017 Jun;32(2):200-218. doi: 10.3803/EnM.2017.32.2.200.
citation: 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 Network for the Study of Adrenal Tumors. Eur J Endocrinol. 2016 Aug;175(2):G1-G34. doi: 10.1530/EJE-16-0467.
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 Cross-Sectional Study. Ann Intern Med. 2022 Oct;175(10):1383-1391. doi: 10.7326/M22-1619. Epub 2022 Sep 13.