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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
U-RYTHM system
DeviceConsent 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: MACS patientsExperimental treatment 1 intervention
Group B: ANS patientsActive comparator 1 intervention
Trial outcomes
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).
Time frame
During day 1Secondary outcomes
1
Assessment of the rhythm and intensity of cortisone production
The secondary outcome is a composite endpoint based on the calculation of five numerical biomarkers of cortisone: (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).
Time frame
During day 12
Assessment of the rhythm and intensity of 18hydroxycortisol production
The secondary outcome is a composite endpoint based on the calculation of five numerical biomarkers of 18hydroxycortisol: (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).
Time frame
During day 13
Assessment of the rhythm and intensity of dehydroandrosténédione production
The secondary outcome is a composite endpoint based on the calculation of five numerical biomarkers of dehydroandrosténédione sulfate (SDHEA): (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).
Time frame
During day 14
Assessment of the rhythm and intensity of allo-tetrahydrocortisol production
The secondary outcome is a composite endpoint based on the calculation of five numerical biomarkers of allo-tetrahydrocortisol: (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).
Time frame
During day 1Sponsors and contacts
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Source ClinicalTrials.gov