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Ultradian Steroid Rhythms in Adrenal Incidentalomas

RecruitingNAAges 18 Years - anyAllUniversity Hospital, Bordeaux
NCT07387419 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • U-RYTHM system
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Where

1 site
Hôpital Haut-Levêque
Pessac, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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