NCT07387419 Ultradian Steroid Rhythms in Adrenal Incidentalomas
| NCT ID | NCT07387419 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Mild Autonomous Cortisol Secretion Adenoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-04-15 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-04-15 with a primary completion date of 2027-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07387419 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Mild Autonomous Cortisol Secretion Adenoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07387419 currently recruiting?
Yes, NCT07387419 is actively recruiting participants. Contact the research team at amandine.ferriere@chu-bordeaux.fr for enrollment information.
Where is the NCT07387419 trial being conducted?
This trial is being conducted at Pessac, France.
Who is sponsoring the NCT07387419 clinical trial?
NCT07387419 is sponsored by University Hospital, Bordeaux. The trial plans to enroll 40 participants.