Natural History of NFAI: 10 Year Follow-up Results

• Conditions: Adrenal Incidentaloma
• Interventions: Radiation: CT imaging

• Registration Number: NCT04616703
• Lead Sponsor: University Medical Centre Ljubljana

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.

Study Timeline

• Study Start: 2019-06-01
• Status Verified: 2020-10
• Study First Submitted: 2020-10-22
• Study First Submitted QC: 2020-10-29
• Last Update Submitted: 2020-10-29
• Study First Posted: 2020-11-05
• Last Update Posted: 2020-11-05
• Primary Completion: 2020-11-15
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BMI 25-30 kg/m2	CT imaging	Those with NFAT and BMI 25-30 kg/m2.
BMI > 30 kg/m2	CT imaging	Those with NFAT and BMI \> 30 kg/m2.
BMI < 25 kg/m2	CT imaging	Those with NFAT and BMI \< 25 kg/m2.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Department of Internal Medicine, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia; 🇸🇮 Ljubljana, Slovenia