RecruitingNot Applicable

Ultradian Steroid Rhythms in Adrenal Incidentalomas

France40 participantsStarted 2026-04-15

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 18 \< 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. Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rhythm and intensity of cortisol production

Timeframe: During day 1

Trial details

NCT IDNCT07387419

SponsorUniversity Hospital, Bordeaux

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10

Contact for this trial

Amandine FERRIERE, Dr

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

View on ClinicalTrials.gov More Mild Autonomous Cortisol Secretion Adenoma trials