Ultradian Steroid Rhythms in Adrenal Incidentalomas
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux
About this trial
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
Qualifiers
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.
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- U-RYTHM system
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov