- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04682938
The Prevalence and Characteristics of Adrenal Incidentaloma
August 7, 2022 updated by: Qifu Li, Chongqing Medical University
The Prevalence and Characteristics of Adrenal Incidentaloma: A Prospective Study
To investige the prevalence, characteristics and prognosis of adrenal incidentalomas in Chinese adults.
Study Overview
Status
Completed
Conditions
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.
Study Type
Observational
Enrollment (Actual)
25356
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Chongqing
-
Chongqing, Chongqing, China, 400016
- the First Affiliated Hospital of Chongqing Medical University, Chongqing, China
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 78 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Chinese community adults
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
adrenal incidentalomas in Chinese community adults
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence and Characteristics of Adrenal Incidentaloma
Time Frame: 1 years
|
To investigate the prevalence and characteristics of Adrenal Incidentaloma in general population in China
|
1 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Steroid hormones in the function of Adrenal Incidentaloma
Time Frame: 1 years
|
prospectively evaluate potential predictive role of combined detection of multiple steroid hormones in the function of Adrenal Incidentaloma
|
1 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Li Qifu, PhD, First Affiliated Hospital of Chongqing Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
November 20, 2020
Primary Completion (ACTUAL)
November 30, 2021
Study Completion (ACTUAL)
November 30, 2021
Study Registration Dates
First Submitted
December 21, 2020
First Submitted That Met QC Criteria
December 21, 2020
First Posted (ACTUAL)
December 24, 2020
Study Record Updates
Last Update Posted (ACTUAL)
August 10, 2022
Last Update Submitted That Met QC Criteria
August 7, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AI-China2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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