Adrenal IncidentalomaITACANCT04127552
Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations
An observational study of Adrenal Incidentaloma and Hypercortisolism, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
The investigators hypothesize that cardiovascular and metabolic alterations can occur in patients with adrenal adenomas and possible Autonomous Cortisol Secretion (pACS). Investigators hypothesize that adrenalectomy in selected patients, following the 2016 European Congress of Endocrinology (ECE) guidelines, can… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Adrenal Incidentaloma, Hypercortisolism, Adrenal Tumor
- What is being tested?
- Adrenalectomy
- Type of treatment
- Surgery or procedure
- How many people
- 68 participants
- Where
- 1 siteItaly
- Study dates
- 2 Jan 2019to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with non-functioning adrenal incidentalomas or adrenal incidentalomas associated with possible autonomous cortisol secretion (subclinical hypercortisolism)
Who may be able to join
- Incidentally detected adrenal mass
Who cannot join
- Patients with overt Cushing's syndrome, pheochromocytoma, Conn syndrome, adrenocortical carcinoma, late-onset congenital adrenal hyperplasia, adrenal metastasis and adrenal hemorrhage
- Patients taking medications influencing glucocorticoid production or metabolism
- Patients with psychiatric diseases or alcohol abuse
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Department of Experimental Medicine
Rome, Italy, 00161
Andrea M Isidori, MD, PhD, +390649970711, andrea.isidori@uniroma1.it
Marianna Minnetti
About this study
Official title: Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations (ITACA Study)
The investigators hypothesize that cardiovascular and metabolic alterations can occur in patients with adrenal adenomas and possible Autonomous Cortisol Secretion (pACS). Investigators hypothesize that adrenalectomy in selected patients, following the 2016 European Congress of Endocrinology (ECE) guidelines, can improve metabolic parameters and cardiovascular risks and features.
Read the detailed description
Adrenal incidentalomas are clinically silent masses discovered inadvertently during diagnostic imaging procedures performed for unrelated reasons. Depending on the criteria applied, up to 50% of patients with adrenal incidentalomas may have biochemical evidence of cortisol excess. Possible autonomous cortisol secretion (pACS), as defined in the 2016 European Society of Endocrinology Guidelines, is characterized by a partial, incomplete suppression of the hypothalamic-pituitary-adrenal (HPA) axis without the typical signs of overt cortisol hypersecretion.
Investigators will perform a prospective longitudinal study in patients with adrenal incidentalomas associated with possible autonomous cortisol secretion, aiming to assess the effect of surgical and conservative management on cardiovascular and metabolic features.
Data will be detected at baseline, at 1 and at 5 years follow-up to quantitatively identify the different cardiovascular and metabolic alterations in: (1) patients with non-functioning adrenal adenoma; (2) patients with possible autonomous cortisol secretion receiving conservative management; (3) patients with possible autonomous cortisol secretion receiving adrenalectomy according to the 2016 European Society of Endocrinology guidelines; (4) patients without adrenal masses.
- Conditions
- Adrenal Incidentaloma, Hypercortisolism, Adrenal Tumor
- Being tested
- Adrenalectomy
- Medical subject headings
- Adrenal incidentaloma, Cushing Syndrome, Adrenal Gland Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdrenalectomyProcedure or surgery
Adrenalectomy according to 2016 ESE guidelines
| Study group | Role | What they receive |
|---|---|---|
| Patients with non-functioning adrenal adenoma | Patients with incidentally discovered adrenal mass with 1mg-DST serum cortisol levels lower than 50 nmol/L | |
| Patients with pACS receiving conservative management | Patients with incidentally discovered adrenal mass with 1mg-DST serum cortisol levels greater than 50 nmol/L receiving conservative management | |
| Patients with pACS receiving adrenalectomy | Patients with incidentally discovered adrenal mass with 1mg-DST serum cortisol levels greater than 50 nmol/L receiving adrenalectomy according to the 2016 European Society of Endocrinology guidelines Receives: Procedure: Adrenalectomy | |
| Healthy controls | Patients without adrenal masses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiographic Change of Left Ventricular Hypertrophy
Change of Left Ventricular Hypertrophy will be evaluated by transthoracic echocardiography. Patients will be examined in the left lateral decubitus position according to the American Society of Echocardiography guidelines.
Measured: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Secondary outcomes (14)
Change of arterial stiffness and blood pressure using brachial oscillometric blood pressure waves for a noninvasive estimation.
Perform non-invasive measurement of arterial stiffness
Measured: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Change of blood pressure using ambulatory blood pressure monitoring blood pressure waves for a noninvasive estimation.
Perform twenty-four-hour systolic and diastolic ambulatory blood pressure monitoring
Measured: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Change in blood Coagulation Tests
Perform blood sampling for coagulative function
Measured: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Change in Dual X-Ray Absorptiometry T-score
Bone mineral density change in spine and femur
Measured: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Radiological evaluation of adrenal mass
Perform adrenal chemical shift MRI or adrenal CT scan (if MRI is contraindicated)
Measured: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Evaluation of sleep disturbances using questionnaire (PSQI)
Perform the Pittsburgh Sleep Quality Index (PSQI). Sleep disturbances will be evaluated by The Pittsburgh Sleep Quality Index (PSQI). This questionnaire contains 19 self-related questions which are combined to create 7 component scores with a range of 0-3 points (0:no difficulty, 3: severe difficulty). Global score is the result to the addition of all component scores with a range of 0-21 points (0:no difficulty, 21: severe difficulty).
Measured: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Infectious diseases frequency and severity with modified German Diseases Questionnaire
Frequencies and severity of infectious diseases will be evaluated by modified Infectious Diseases Questionnaire (GNC).
This questionnaire includes questions on infectious diseases of upper and lower respiratory tract, gastrointestinal tract, skin and urogenital tract and flu contracted during the previous 12 months. Questions investigate on the number and duration of infections, necessity of antibiotic or antifungal therapy, hospital stay and days of absence from work. Final score represents the frequency of infections.
Measured: Baseline (T0), after 1 year (t1) and 5 years (t2)
Quality of life: SF-36-Item Health Survey questionnaire
Quality of life will be evaluated by the Physical Component score and the Mental Component score of the self-administered questionnaire SF-36-Item Health Survey questionnaire.
This questionnaire measures eight scales: physical functioning, role physical, bodily pain, general health (physical component) and vitality, social functioning, role emotional, mental health (mental component).
Interpretation of the score will be the following: at each item of the questionnaire corresponds a percentage value (from 0% to 100%). The average of the single items constitutes the scale total percentage (from 0% to 100%); missing data are not considered during calculation. High score defines a more favorable health state.
Measured: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Psychometric Evaluation: Beck Depression Inventory questionnaire
Psychometric evaluation will be assessed by the score of Beck depression Index: a 21-item measure of depressive symptoms. Each answer is scored on a scale value (from 0 to 3 points). The global score is obtained adding all single scores, with a range of 0-63. Higher score constitutes worse burden of symptoms (0-13: minimal depression, 14-19: mild depression, 20-28: moderate depression, 29-63: severe depression).
Measured: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Evaluation of sexual dysfunction using FSFI questionnaire in woman
Perform the Female Sexual Function Index (FSFI) questionnaire. This is a 19-item questionnaire that covers six domains: desire, arousal, lubrication, and orgasm, satisfaction, and pain. The ranges of the domain scores are as follows: for desire 1.2 - 6.0, for arousal, lubrication, orgasm and pain 0 - 6.0 and for satisfaction 0.8 - 6.0. The higher scores of the six domains indicate better sexual functioning about that domain. The overall FSFI score is obtained by summing the six domain scores. The overall FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.
Measured: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Evaluation of sexual dysfunction using IIEF questionnaire in man
Perform the International Index of Erectile Function (IIEF) questionnaire in man. The IIEF is an internationally validated test. It is used to assign a score of erectile dysfunction: severe score 1 to 10; moderate score 11 to 16; low to moderate score 17 to 21; Low score 22 to 25; no erectile dysfunction score 26 to 30
Measured: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Change in insulin resistance calculated with HOMA index
Measurement of HOMA index calculated according to the formula: fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5.
Measured: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Change in measurement of weight
Measurement of body weight (kg)
Measured: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Change in blood lipid profile
Measurement of Total Cholesterol, LDL cholesterol, HDL cholesterol, triglycerides
Measured: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start2 Jan 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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 University of Roma La SapienzaThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea M. Isidori, University of Roma La Sapienza
- Investigators
- Andrea M Isidori, MD, PHD, Principal investigator, Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04127552
- Sponsor's protocol ID
- ITACA
- Acronym
- ITACA
- Status last verified
- Mar 2025
- First submitted
- 6 Oct 2019
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
De Alcubierre D, Ferrari D, Tomaselli A, Moscucci F, Bonaventura I, Francia A, Vozza E, Lospinuso I, Ettorre E, Hasenmajer V, Minnetti M, Sbardella E, Tenuta M, Morelli S, Paganini AM, Isidori AM, Pofi R. Long-term cardiac effects of adrenalectomy versus surveillance in mild cortisol excess: 5-year results from the prospective ITACA study. Eur J Endocrinol. 2026 Feb 4;194(2):170-184. doi: 10.1093/ejendo/lvag018.
PubMed 41572809
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Adrenal IncidenTalomas and Possible Autonomous Cortisol Secretion on Cardiovascular and Metabolic Alterations (ITACA Study)
- ClinicalTrials.gov ID
- NCT04127552
- Acronym / sponsor ID
- ITACA / ITACA
- Conditions
- Adrenal Incidentaloma, Hypercortisolism, Adrenal Tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Oct 2019 (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 investigators hypothesize that cardiovascular and metabolic alterations can occur in patients with adrenal adenomas and possible Autonomous Cortisol Secretion (pACS). Investigators hypothesize that adrenalectomy in selected patients, following the 2016 European Congress of Endocrinology (ECE) guidelines, can improve metabolic parameters and cardiovascular risks and features.
Detailed description
Adrenal incidentalomas are clinically silent masses discovered inadvertently during diagnostic imaging procedures performed for unrelated reasons. Depending on the criteria applied, up to 50% of patients with adrenal incidentalomas may have biochemical evidence of cortisol excess. Possible autonomous cortisol secretion (pACS), as defined in the 2016 European Society of Endocrinology Guidelines, is characterized by a partial, incomplete suppression of the hypothalamic-pituitary-adrenal (HPA) axis without the typical signs of overt cortisol hypersecretion.
Investigators will perform a prospective longitudinal study in patients with adrenal incidentalomas associated with possible autonomous cortisol secretion, aiming to assess the effect of surgical and conservative management on cardiovascular and metabolic features.
Data will be detected at baseline, at 1 and at 5 years follow-up to quantitatively identify the different cardiovascular and metabolic alterations in: (1) patients with non-functioning adrenal adenoma; (2) patients with possible autonomous cortisol secretion receiving conservative management; (3) patients with possible autonomous cortisol secretion receiving adrenalectomy according to the 2016 European Society of Endocrinology guidelines; (4) patients without adrenal masses.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with non-functioning adrenal adenoma | – | –Patients with incidentally discovered adrenal mass with 1mg-DST serum cortisol levels lower than 50 nmol/L |
| Patients with pACS receiving conservative management | – | –Patients with incidentally discovered adrenal mass with 1mg-DST serum cortisol levels greater than 50 nmol/L receiving conservative management |
| Patients with pACS receiving adrenalectomy | – | Procedure: AdrenalectomyPatients with incidentally discovered adrenal mass with 1mg-DST serum cortisol levels greater than 50 nmol/L receiving adrenalectomy according to the 2016 European Society of Endocrinology guidelines |
| Healthy controls | – | –Patients without adrenal masses |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with non-functioning adrenal incidentalomas or adrenal incidentalomas associated with possible autonomous cortisol secretion (subclinical hypercortisolism)
Key inclusion criteria (1 listed)
- Incidentally detected adrenal mass
Key exclusion criteria (4 listed)
- Patients with overt Cushing's syndrome, pheochromocytoma, Conn syndrome, adrenocortical carcinoma, late-onset congenital adrenal hyperplasia, adrenal metastasis and adrenal hemorrhage
- Patients taking medications influencing glucocorticoid production or metabolism
- Patients with psychiatric diseases or alcohol abuse
- Pregnancy
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 |
|---|---|---|
| AdrenalectomyAdrenalectomy according to 2016 ESE guidelines | Procedure or surgery | Patients with pACS receiving adrenalectomy |
Primary outcome
Echocardiographic Change of Left Ventricular Hypertrophy
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Change of Left Ventricular Hypertrophy will be evaluated by transthoracic echocardiography. Patients will be examined in the left lateral decubitus position according to the American Society of Echocardiography guidelines.
14 secondary outcomes
Change of arterial stiffness and blood pressure using brachial oscillometric blood pressure waves for a noninvasive estimation.
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Change of blood pressure using ambulatory blood pressure monitoring blood pressure waves for a noninvasive estimation.
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Change in blood Coagulation Tests
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Change in Dual X-Ray Absorptiometry T-score
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Radiological evaluation of adrenal mass
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Evaluation of sleep disturbances using questionnaire (PSQI)
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Infectious diseases frequency and severity with modified German Diseases Questionnaire
Time frame: Baseline (T0), after 1 year (t1) and 5 years (t2)
Quality of life: SF-36-Item Health Survey questionnaire
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Psychometric Evaluation: Beck Depression Inventory questionnaire
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Evaluation of sexual dysfunction using FSFI questionnaire in woman
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Evaluation of sexual dysfunction using IIEF questionnaire in man
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Change in insulin resistance calculated with HOMA index
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Change in measurement of weight
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Change in blood lipid profile
Time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Derived from this study: PubMed 41572809De Alcubierre D, Ferrari D, Tomaselli A, Moscucci F, Bonaventura I, Francia A, Vozza E, Lospinuso I, Ettorre E, Hasenmajer V, Minnetti M, Sbardella E, Tenuta M, Morelli S, Paganini AM, Isidori AM, Pofi R. Long-term cardiac effects of adrenalectomy versus surveillance in mild cortisol excess: 5-year results from the prospective ITACA study. Eur J Endocrinol. 2026 Feb 4;194(2):170-184. doi: 10.1093/ejendo/lvag018.
- 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.
Andrea M Isidori, MD, PHD principal investigator
Sapienza
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 Hypercortisolism, run by University of Roma La Sapienza at 1 site in Italy.
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 4 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: looking for participants now, as of the sponsor's last update on 28 Mar 2025. 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 Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echocardiographic Change of Left Ventricular Hypertrophy (time frame: at Baseline (T0) and after 1 year (t1) and 5 years (t2)). 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 NCT04127552, 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 28 Mar 2025.