Adrenal IncidentalomaNCT04833192
Evaluation of New Diagnostic Indicator of Subclinical Hypercortisolism
An observational study of Adrenal Incidentaloma and Subclinical Hypercortisolism, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
The purpose of this study is to evaluate the serum dehydroepiandrosterone sulfate in subclinical hypercortisolism Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Adrenal Incidentaloma, Subclinical Hypercortisolism
- What is being tested?
- experimental group
- How many people
- 202 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 30 Dec 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: subclinical hypercortisolism and adrenal nonfunctional adenoma patients
Who may be able to join
- patients with adrenal accidental tumor (diameter > 1cm) found by physical examination or imaging examination due to non-adrenal diseases
Who cannot join
- concomitant use of drugs influencing glucocorticoid metabolism or secretion
- major psychiatric illness or history of excess alcohol intake
- overt clinical features of hypercortisolism
- clinical and endocrine function evaluation (surgery patients at the same time reference to postoperative pathology) revealed primary aldosteronism, pheochromocytoma, adrenocortical carcinoma, adrenal metastasis of cancer, myelolipoma; oncocytoma, congenital adrenal cortex hyperplasia and ganglion cells neuroma/paraganglioma, schwannoma, adrenal hematoma and uncertain diagnosis)
- non-adenoma lesions such as cysts and hemorrhage
- The pregnancy
- Patients with severe underlying diseases (such as liver and kidney failure, acute severe infection, etc.) that may affect the function of the hypothalamus-pituitary-adrenal axis (HPA axis)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
at Divison of Endocrinology,the Affiliated Drum Tower Hospital of Nanjing University
Nanjing, Jiangsu, 210008
Dalong Zhu, MD,PhD, 86-25-83-105302, zhudldr@gmail.com
Ping Li, MD,PhD, 86-25-83-105302, lp78321@yeah.net
About this study
Official title: The Cross-sectional Study and Longitudinal Study of the Diagnostic Efficiency of Serum Dehydroepiandrosterone Sulfate in Subclinical Hypercortisolism
The purpose of this study is to evaluate the serum dehydroepiandrosterone sulfate in subclinical hypercortisolism
Read the detailed description
In the past few years, with the widespread use of chest and abdominal imaging, the prevalence of adrenal incidentaloma (AIs) has been increasing and now approaches the 8.7% incidence reported in autopsy series. subclinical hypercortisolism (SH) is noted in up to 30% of patients with adrenal incidentalomas. Several groups have reported adverse clinical sequelae in individuals with SH, with recent studies highlighting an increase in cardiovascular morbidity and mortality compared to the general population. Accurate exclusion or confirmation of a diagnosis of SH is therefore a key step in the investigation and management of patients with AIs. Suppressed adrenocorticotropic hormone (ACTH) and low dehydroepiandrosterone sulfate (DHEAS) levels are frequently found in SH patients. Present study added new evidence for the limitations of ACTH and confirmed the usefulness of DHEAS for the detection of SH especially with unsuppressed ACTH in AI patients. On one hand, in the cross-sectional study, biometric measurements and sex hormones (including DHEAS, 24h-UFC, ACTH and cortisol) are analysed to explore the differences among SH patients, and nonfunctional adrenal adenoma patients. One the other hand, in the longitudinal study, changes in DHEAS, ACTH and cortisol in SH with surgical management and SH with conservative management both at baseline and different follow-up months after their different treatment management are collected to explore the changes of DHEAS and ACTH of SH patients.
- Being tested
- experimental group
- Keywords
- serum dehydroepiandrosterone sulfate, adrenocorticotropic hormone, surgical management, conservative management
- Medical subject headings
- Adrenal incidentaloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
experimental groupDiagnostic test
DHEAS.24h-UFC,ACTH and cortisol are measured in the experimental group
| Study group | Role | What they receive |
|---|---|---|
| experimental group | patients diagnosed with subclinical hypercortisolism as assessed by an endocrinologist. Receives: Diagnostic Test: experimental group | |
| control grpup | patients diagnosed with nonfunctional adrenal adenoma as assessed by an endocrinologist. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The gender and age of the participants
age in years and sex (female or male) of patients
Measured: 1 day
Participant's weight and height
BMI(body mess index) in kg/m^2= (weight in kg) /(height in m)^2
Measured: 1 day
the diurnal rhythm of ACTH
plasma ACTH in pmol/L at 8:00 am, 16:00 pm and 24:00 midnight
Measured: 2 day
the the diurnal rhythm of cortisol
serum cortisol in nmol/L at 8:00 am, 16:00 pm and 24:00 midnight measured on the same day as plasma ACTH
Measured: 2 day
Patients' baseline DHEAS level
serum DHEAS in ug/dL
Measured: 1 day
CT imaging of adrenal tumor
diameter in cm of adrenal adenoma
Measured: 1 day
dexamethasone suppression test
Dexamethasone 1mg (0.75mg/ tablet, 1.5 tablets) was taken orally at 24:00 midnight, and plasma ACTH in pmol/L and serum cortisol in cortisol levels were measured by blood sample at 8:00 the next day
Measured: 2 day
Secondary outcomes (6)
the changes of DHEAS after surgical management
DHEAS in ug/dL
Measured: 1,3,6 and12 months after the surgical management (for subclinical hypercortisolism with surgical managment)
the changes of ACTH after surgical management
ACTH in pmol/L
Measured: 1,3,6 and12 months after the surgical management (for subclinical hypercortisolism with surgical managment)
the changes of cortisol after surgical management
cortisol in nmol/L
Measured: 1,3,6 and12 months after the surgical management (for subclinical hypercortisolism with surgical managment)
the changes of DHEAS after conservative management
DHEAS in ug/dL
Measured: 12 months after the conservative management (for subclinical hypercortisolism with conservative management)
the changes of ACTH after conservative management
ACTH in pmol/L
Measured: 12 months after the conservative management (for subclinical hypercortisolism with conservative management)
the changes of cortisol after conservative management
cortisol in nmol/L
Measured: 12 months after the conservative management (for subclinical hypercortisolism with conservative management)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start1 Apr 2020
- Primary completion1 Apr 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adrenal IncidentalomaStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 202 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dalong Zhu, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833192
- Sponsor's protocol ID
- LP2021
- Status last verified
- Apr 2022
- First submitted
- 24 Jan 2021
- Last updated
- 15 Apr 2022
- Results posted
- No
- Individual data sharing
- No
Publications
Liu MS, Lou Y, Chen H, Wang YJ, Zhang ZW, Li P, Zhu DL. Performance of DHEAS as a Screening Test for Autonomous Cortisol Secretion in Adrenal Incidentalomas: A Prospective Study. J Clin Endocrinol Metab. 2022 Apr 19;107(5):e1789-e1796. doi: 10.1210/clinem/dgac072.
PubMed 35137142
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cross-sectional Study and Longitudinal Study of the Diagnostic Efficiency of Serum Dehydroepiandrosterone Sulfate in Subclinical Hypercortisolism
- ClinicalTrials.gov ID
- NCT04833192
- Acronym / sponsor ID
- LP2021
- Keywords
- serum dehydroepiandrosterone sulfate, adrenocorticotropic hormone, surgical management, conservative management
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 202 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 6 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the serum dehydroepiandrosterone sulfate in subclinical hypercortisolism
Detailed description
In the past few years, with the widespread use of chest and abdominal imaging, the prevalence of adrenal incidentaloma (AIs) has been increasing and now approaches the 8.7% incidence reported in autopsy series. subclinical hypercortisolism (SH) is noted in up to 30% of patients with adrenal incidentalomas. Several groups have reported adverse clinical sequelae in individuals with SH, with recent studies highlighting an increase in cardiovascular morbidity and mortality compared to the general population. Accurate exclusion or confirmation of a diagnosis of SH is therefore a key step in the investigation and management of patients with AIs. Suppressed adrenocorticotropic hormone (ACTH) and low dehydroepiandrosterone sulfate (DHEAS) levels are frequently found in SH patients. Present study added new evidence for the limitations of ACTH and confirmed the usefulness of DHEAS for the detection of SH especially with unsuppressed ACTH in AI patients. On one hand, in the cross-sectional study, biometric measurements and sex hormones (including DHEAS, 24h-UFC, ACTH and cortisol) are analysed to explore the differences among SH patients, and nonfunctional adrenal adenoma patients. One the other hand, in the longitudinal study, changes in DHEAS, ACTH and cortisol in SH with surgical management and SH with conservative management both at baseline and different follow-up months after their different treatment management are collected to explore the changes of DHEAS and ACTH of SH patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | – | Diagnostic Test: experimental grouppatients diagnosed with subclinical hypercortisolism as assessed by an endocrinologist. |
| control grpup | – | –patients diagnosed with nonfunctional adrenal adenoma as assessed by an endocrinologist. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- subclinical hypercortisolism and adrenal nonfunctional adenoma patients
Key inclusion criteria (1 listed)
- patients with adrenal accidental tumor (diameter > 1cm) found by physical examination or imaging examination due to non-adrenal diseases
Key exclusion criteria (7 listed)
- concomitant use of drugs influencing glucocorticoid metabolism or secretion
- major psychiatric illness or history of excess alcohol intake
- overt clinical features of hypercortisolism
- clinical and endocrine function evaluation (surgery patients at the same time reference to postoperative pathology) revealed primary aldosteronism, pheochromocytoma, adrenocortical carcinoma, adrenal metastasis of cancer, myelolipoma; oncocytoma, congenital adrenal cortex hyperplasia and ganglion cells neuroma/paraganglioma, schwannoma, adrenal hematoma and uncertain diagnosis)
- non-adenoma lesions such as cysts and hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| experimental groupDHEAS.24h-UFC,ACTH and cortisol are measured in the experimental group | Diagnostic test | experimental group |
Primary outcome
The gender and age of the participants
Time frame: 1 day
age in years and sex (female or male) of patients
Participant's weight and height
Time frame: 1 day
BMI(body mess index) in kg/m^2= (weight in kg) /(height in m)^2
the diurnal rhythm of ACTH
Time frame: 2 day
plasma ACTH in pmol/L at 8:00 am, 16:00 pm and 24:00 midnight
the the diurnal rhythm of cortisol
Time frame: 2 day
serum cortisol in nmol/L at 8:00 am, 16:00 pm and 24:00 midnight measured on the same day as plasma ACTH
Patients' baseline DHEAS level
Time frame: 1 day
serum DHEAS in ug/dL
CT imaging of adrenal tumor
Time frame: 1 day
diameter in cm of adrenal adenoma
dexamethasone suppression test
Time frame: 2 day
Dexamethasone 1mg (0.75mg/ tablet, 1.5 tablets) was taken orally at 24:00 midnight, and plasma ACTH in pmol/L and serum cortisol in cortisol levels were measured by blood sample at 8:00 the next day
6 secondary outcomes
the changes of DHEAS after surgical management
Time frame: 1,3,6 and12 months after the surgical management (for subclinical hypercortisolism with surgical managment)
the changes of ACTH after surgical management
Time frame: 1,3,6 and12 months after the surgical management (for subclinical hypercortisolism with surgical managment)
the changes of cortisol after surgical management
Time frame: 1,3,6 and12 months after the surgical management (for subclinical hypercortisolism with surgical managment)
the changes of DHEAS after conservative management
Time frame: 12 months after the conservative management (for subclinical hypercortisolism with conservative management)
the changes of ACTH after conservative management
Time frame: 12 months after the conservative management (for subclinical hypercortisolism with conservative management)
the changes of cortisol after conservative management
Time frame: 12 months after the conservative management (for subclinical hypercortisolism with conservative management)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Derived from this study: PubMed 35137142Liu MS, Lou Y, Chen H, Wang YJ, Zhang ZW, Li P, Zhu DL. Performance of DHEAS as a Screening Test for Autonomous Cortisol Secretion in Adrenal Incidentalomas: A Prospective Study. J Clin Endocrinol Metab. 2022 Apr 19;107(5):e1789-e1796. doi: 10.1210/clinem/dgac072.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenal Incidentaloma and Subclinical Hypercortisolism, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dalong Zhu, MD,PhD (13805150781, zhudldr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The gender and age of the participants (time frame: 1 day). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04833192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.