Ultradian Steroid Rhythms in Adrenal Incidentalomas

NCT07387419 | Recruiting

• 1 other identifier: CHUBX 2025/067
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Twenty to 40% of adrenal incidentalomas are responsible for MACS (mild autonomous cortisol producing secretion). The biological tools used in current practice to explore MACS do not provide precise information on cortisol production abnormalities. This study is a comparative analysis of the dynamics/rhythmicity of interstitial cortisol and other steroid concentrations between MACS and non-secreting adenomas (ANS). Using the original and innovative U-RHYTHM system, interstitial fluid samples will be taken every 20 minutes for 24 to 48 hours from patients with MACS or non-secreting adenomas, and steroid assays will be performed in the perfusates to analyze steroid hormone production over 24 hours.

Conditions

Mild Autonomous Cortisol Secretion Adenoma; Non Secreting Adenoma

Keywords

Adrenal incidentaloma; Mild autonomous cortisol secretion adenoma; Ultradian steroid rhythms

Outcome Measures

Primary Outcomes (1)

• Rhythm and intensity of cortisol production

  The primary outcome is a composite endpoint based on the calculation of five numerical biomarkers of cortisol: (i) area under the curve (AUC) during the day (6:00-18:00) ; (ii) AUC during the night (6:00 p.m. to 6:00 a.m.); (iii) peak-to-nadir ratio (PNR) between morning peak (3:00-12:00) and night nadir; (iv) night nadir time (NNT); (v) morning peak time (MPT).

  During day 1

Secondary Outcomes (6)

• Assessment of the rhythm and intensity of cortisone production

  During day 1

• Assessment of the rhythm and intensity of 18hydroxycortisol production

  During day 1

• Assessment of the rhythm and intensity of dehydroandrosténédione production

  During day 1

• Assessment of the rhythm and intensity of allo-tetrahydrocortisol production

  During day 1

• Assessment of the rhythm and intensity of tetrahydrocortisol production

  During day 1

Study Arms (2)

MACS patients

EXPERIMENTAL

Analysis of the dynamics/rhythmicity of interstitial cortisol and other steroid concentrations thanks to U-RHYTHM system, in MACS patients

Device: U-RYTHM system

ANS patients

ACTIVE COMPARATOR

Analysis of the dynamics/rhythmicity of interstitial cortisol and other steroid concentrations thanks to an original and innovative U-RHYTHM system, interstitial fluid samples, in ANS patients

Device: U-RYTHM system

Interventions

U-RYTHM system DEVICE

Consent will be obtained at inclusion. The patient will be seen by the investigating physician twice, 27 hours apart, for insertion and removal of the U-RHYTHM system. Microdialysis samples will be collected in the collection system. Samples will be directly frozen at -20°C or -80°C and transported at -20°C to the Ultradian Analysis Laboratory, Metabolomics Centre, Department of Clinical Sciences, University of Bergen, Norway, for sample preparation, LC-MSMS steroid profiling (panel of 21 steroids) and statistical analysis. The research protocol does not include patient follow-up.

ANS patients; MACS patients

Eligibility Criteria

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

You may qualify if:

• \< Age ≤ 85 years.
• Patient with one or more uni or bilateral adrenal nodules of cortical appearance on CT scan.
• Subject affiliated or beneficiary of a social security scheme.
• The diagnostic criteria are:
• For the MACS group:
• a serum cortisol concentration after a minute braking test with dexamethasone \> 50 nmol/L or 1.8 µg/dL, with a concomitant dexamethasone concentration above the test validation threshold
• morning plasma ACTH concentration ≤ 2.5 pmol/L or 11 pg/mL.
• For the non-secreting adenoma group:
• \- Plasma cortisol after minute dexamethasone braking test ≤ 50 nmol/L or 1.8 µg/dL.

You may not qualify if:

• Age \< 18 years
• Pregnant or breast-feeding
• Use of oral estrogens (must be discontinued for at least 6 weeks prior to sampling)
• Known adrenal insufficiency and/or treatment with steroids (oral, inhaled, parenteral or topical) or other interfering drugs.
• patient taking part in another study
• Patients placed under legal protection measures and/or deprived of their liberty

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Hôpital Haut-Levêque

Pessac, 33600, France

RECRUITING

MeSH Terms

Conditions

Adrenal incidentaloma

Central Study Contacts

Amandine FERRIERE, Dr

CONTACT

05 57 57 64 24; amandine.ferriere@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 4, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Locations

FR (1)