Adrenal IncidentalomaNCT04616703
Natural History of NFAI: 10 Year Follow-up Results
An observational study of Adrenal Incidentaloma, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The data on long term natural history of benign nonfunctioning adrenal tumors (NFATs) are lacking. The aim is to identify clinical characteristics associated with tumor growth and progression to mild autonomous cortisol excess over time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adrenal Incidentaloma
- What is being tested?
- CT imaging
- Type of treatment
- Surgery or procedure
- How many people
- 65 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jun 2019to 1 Dec 2020
- How long will I take part?
- 10 Years
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with diagnosisi of NFAI, hospitalized between 2005-2012 at the Department of Endocrinology, Diabetes and Metabolic Disease, University Medical Center Ljubljana, Ljubljana, Slovenia.
Who may be able to join
- Patients hospitalized because of NFAI between 2005-2012 at the Department of Endocrinology, Diabetes and Metabolic Disease, University Medical Center Ljubljana, Ljubljana, Slovenia.
Who cannot join
- age below 18 years
- relatives reported that patient died in the time since hospitalization
- patient did not want a follow up
- patient did not attend follow up appointment
- patient underwent adrenalectomy
- misdiagnosis / missing main information in hospitalization record
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
Department of Internal Medicine, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia
Ljubljana, 1000
Mojca Jensterle, MD, PhD, 0o3861 522 50 5, mojca.jensterlesever@kclj.si
About this study
Official title: Natural History of Benign Nonfunctioning Adrenal Tumors: 10 Year Follow-up Results
The data on long term natural history of benign nonfunctioning adrenal tumors (NFATs) are lacking. The aim is to identify clinical characteristics associated with tumor growth and progression to mild autonomous cortisol excess over time.
Read the detailed description
After being informed about the study, all patients with NFAT given written informed consent will underwent a control visit approximatly 10 years after initial visit at the outpateint clinic at the Department of Endocrinology, Diabetes and Metabolic Disease, University Medical Center Ljubljana, Ljubljana, Slovenia. The included patients will be divided in three groups regarding the BMI as follows: BMI < 25 kg/m2, 25-30 kg/m2 and > 30 kg/m2. The investigators will assess clinical, and laboratory parameters and CT findings at the follow up visit and compere them to baseline characteristics.
- Conditions
- Adrenal Incidentaloma
- Being tested
- CT imaging
- Keywords
- adrenal incidentaloma, BMI, NFAI, MACE, long term follow up, natural history
- Medical subject headings
- Adrenal incidentaloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT imagingRadiation
CT of abdomen
| Study group | Role | What they receive |
|---|---|---|
| BMI < 25 kg/m2 | Those with NFAT and BMI < 25 kg/m2. Receives: Radiation: CT imaging | |
| BMI 25-30 kg/m2 | Those with NFAT and BMI 25-30 kg/m2. Receives: Radiation: CT imaging | |
| BMI > 30 kg/m2 | Those with NFAT and BMI > 30 kg/m2. Receives: Radiation: CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Natural History of NFAT - horomnal activity
To determine if and in how many pateints NFAI progressed to MACE.
NFAI: when cortisol after 1 mg overnight dexamethasone (ODST) suppression test is < 50 nmol/l and no typical clinical signs of Cushing's syndrome are present. Pheochromocytoma and primary aldosteronism will be excluded.
MACE: when cortisol after 1 mg overnight dexamethasone (ODST) suppression test is > 50 nmol/l.
Measured: 10 years
Natural History of NFAT - growth
To determine the change in size of NFAI on the CT scan (mm).
Measured: 10 years
Natural History of NFAT - BMI
To determine the change in BMI and its correlation with outcome 1 and 2.
Weight and height will be combined to report BMI in kg/m^2.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start1 Jun 2019
- Primary completion15 Nov 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal IncidentalomaStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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
- 65 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana, Faculty of Medicine, University Rehabilitation Institute, Republic of Slovenia
- Responsible party
- Principal investigator, Mojca Jensterle, University Medical Centre Ljubljana
- Investigators
- Mojca Jensterle, MD, PhD, Study director, University Medical Center Ljubljana, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04616703
- Sponsor's protocol ID
- 00000
- Status last verified
- Oct 2020
- First submitted
- 22 Oct 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History of Benign Nonfunctioning Adrenal Tumors: 10 Year Follow-up Results
- ClinicalTrials.gov ID
- NCT04616703
- Acronym / sponsor ID
- 00000
- Conditions
- Adrenal Incidentaloma
- Keywords
- adrenal incidentaloma, BMI, NFAI, MACE, long term follow up, natural history
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- University of Ljubljana, Faculty of Medicine, University Rehabilitation Institute, Republic of Slovenia
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 15 Nov 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 5 Nov 2020 (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 data on long term natural history of benign nonfunctioning adrenal tumors (NFATs) are lacking. The aim is to identify clinical characteristics associated with tumor growth and progression to mild autonomous cortisol excess over time.
Detailed description
After being informed about the study, all patients with NFAT given written informed consent will underwent a control visit approximatly 10 years after initial visit at the outpateint clinic at the Department of Endocrinology, Diabetes and Metabolic Disease, University Medical Center Ljubljana, Ljubljana, Slovenia. The included patients will be divided in three groups regarding the BMI as follows: BMI < 25 kg/m2, 25-30 kg/m2 and > 30 kg/m2. The investigators will assess clinical, and laboratory parameters and CT findings at the follow up visit and compere them to baseline characteristics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BMI < 25 kg/m2 | – | Radiation: CT imagingThose with NFAT and BMI < 25 kg/m2. |
| BMI 25-30 kg/m2 | – | Radiation: CT imagingThose with NFAT and BMI 25-30 kg/m2. |
| BMI > 30 kg/m2 | – | Radiation: CT imagingThose with NFAT and BMI > 30 kg/m2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with diagnosisi of NFAI, hospitalized between 2005-2012 at the Department of Endocrinology, Diabetes and Metabolic Disease, University Medical Center Ljubljana, Ljubljana, Slovenia.
Key inclusion criteria (1 listed)
- Patients hospitalized because of NFAI between 2005-2012 at the Department of Endocrinology, Diabetes and Metabolic Disease, University Medical Center Ljubljana, Ljubljana, Slovenia.
Key exclusion criteria (6 listed)
- age below 18 years
- relatives reported that patient died in the time since hospitalization
- patient did not want a follow up
- patient did not attend follow up appointment
- patient underwent adrenalectomy
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 |
|---|---|---|
| CT imagingCT of abdomen | Radiation | BMI 25-30 kg/m2, BMI < 25 kg/m2, BMI > 30 kg/m2 |
Primary outcome
Natural History of NFAT - horomnal activity
Time frame: 10 years
To determine if and in how many pateints NFAI progressed to MACE. NFAI: when cortisol after 1 mg overnight dexamethasone (ODST) suppression test is < 50 nmol/l and no typical clinical signs of Cushing's syndrome are present. Pheochromocytoma and primary aldosteronism will be excluded. MACE: when cortisol after 1 mg overnight dexamethasone (ODST) suppression test is > 50 nmol/l.
Natural History of NFAT - growth
Time frame: 10 years
To determine the change in size of NFAI on the CT scan (mm).
Natural History of NFAT - BMI
Time frame: 10 years
To determine the change in BMI and its correlation with outcome 1 and 2. Weight and height will be combined to report BMI in kg/m^2.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2020.
- 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.
Mojca Jensterle, MD, PhD study director
University Medical Center Ljubljana, Slovenia
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, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 6 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 5 Nov 2020. 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 Slovenia. 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 Mojca Jensterle, MD, PhD (003861 522 50 50, mojca.jensterlesever@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Natural History of NFAT - horomnal activity (time frame: 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2020.