Natural History of NFAI: 10 Year Follow-up Results

NCT04616703 | Unknown

• 1 other identifier: 00000
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Adrenal Incidentaloma

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

BMI < 25 kg/m2

Those with NFAT and BMI \< 25 kg/m2.

Radiation: CT imaging

BMI 25-30 kg/m2

Those with NFAT and BMI 25-30 kg/m2.

Radiation: CT imaging

BMI > 30 kg/m2

Those with NFAT and BMI \> 30 kg/m2.

Radiation: CT imaging

Interventions

CT imaging RADIATION

CT of abdomen

BMI 25-30 kg/m2; BMI < 25 kg/m2; BMI > 30 kg/m2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead
• University of Ljubljana, Faculty of Medicine: collaborator
• University Rehabilitation Institute, Republic of Slovenia: collaborator

Study Sites (1)

Department of Internal Medicine, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia

Ljubljana, 1000, Slovenia

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

venous blood sample

MeSH Terms

Conditions

Adrenal incidentaloma

Interventions

Postmortem Imaging

Intervention Hierarchy (Ancestors)

Autopsy; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Investigative Techniques

Study Officials

• Mojca Jensterle, MD, PhD

  University Medical Center Ljubljana, Slovenia

  STUDY DIRECTOR

Central Study Contacts

Mojca Jensterle, MD, PhD

CONTACT

003861 522 50 50; mojca.jensterlesever@kclj.si

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: November 5, 2020
• Study Start: June 1, 2019
• Primary Completion: November 15, 2020
• Study Completion: December 1, 2020
• Last Updated: November 5, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)