Natural History of NFAI: 10 Year Follow-up Results

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.

Study Overview

• Status: Unknown
• Conditions: Adrenal Incidentaloma
• Intervention / Treatment: Radiation: CT imaging

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 Type: Observational
• Enrollment (Anticipated): 65

Contacts and Locations

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • Department of Internal Medicine, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BMI < 25 kg/m2; Those with NFAT and BMI < 25 kg/m2.	Radiation: CT imaging; CT of abdomen
BMI 25-30 kg/m2; Those with NFAT and BMI 25-30 kg/m2.	Radiation: CT imaging; CT of abdomen
BMI > 30 kg/m2; Those with NFAT and BMI > 30 kg/m2.	Radiation: CT imaging; CT of abdomen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	10 years
Natural History of NFAT - growth	To determine the change in size of NFAI on the CT scan (mm).	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.	10 years

Collaborators and Investigators

• Sponsor: University Medical Centre Ljubljana
• Collaborators: University Rehabilitation Institute, Republic of Slovenia; University of Ljubljana, Faculty of Medicine
• Investigators: Study Director: Mojca Jensterle, MD, PhD, University Medical Center Ljubljana, Slovenia

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2019
• Primary Completion (ANTICIPATED): November 15, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: October 22, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (ACTUAL): November 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 5, 2020
• Last Update Submitted That Met QC Criteria: October 29, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: BMI; MACE; natural history; adrenal incidentaloma; long term follow up; NFAI
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Adrenal Gland Diseases; Adrenal Cortex Neoplasms; Adrenal Gland Neoplasms; Adrenal Cortex Diseases; Adrenocortical Adenoma
• Other Study ID Numbers: 00000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No