Natural History of NFAI: 10 Year Follow-up Results

Natural History of Benign Nonfunctioning Adrenal Tumors: 10 Year Follow-up Results

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04616703

Enrollment

Registered

2020-11-05

Start date

2019-06-01

Completion date

2020-12-01

Last updated

2020-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenal Incidentaloma

Keywords

adrenal incidentaloma, BMI, NFAI, MACE, long term follow up, natural history

Brief 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.

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.

Interventions

RADIATIONCT imaging

CT of abdomen

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

\- Patients hospitalized because of NFAI between 2005-2012 at the Department of Endocrinology, Diabetes and Metabolic Disease, University Medical Center Ljubljana, Ljubljana, Slovenia.

Exclusion criteria

* 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

Design outcomes

Primary

Measure	Time frame	Description
Natural History of NFAT - horomnal activity	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	10 years	To determine the change in size of NFAI on the CT scan (mm).
Natural History of NFAT - BMI	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.

Countries

Slovenia

Contacts

Primary ContactMojca Jensterle, MD, PhD

mojca.jensterlesever@kclj.si003861 522 50 50

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026