Short-term cortisol and steroid rhythms in adrenal incidentalomas
Official title: Ultradian Steroid Rhythms in Adrenal Incidentalomas
Run by University Hospital, Bordeaux · NCT07387419 · Data updated 2026-11-12
The team will try a sampling system that takes interstitial fluid every 20 minutes to see if people with mild cortisol-producing adrenal nodules have different daily cortisol and steroid rhythms than people with non-secreting nodules.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Pessac) |
| Status | Recruiting |
| Started | April 15, 2026 |
| Main results expected | October 2027 |
| Study ends | October 2027 |
| Registry record updated | April 23, 2026 |
| Trial ID | NCT07387419 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–85 with one or more adrenal nodules on CT who meet the study's diagnostic criteria for MACS or for non-secreting adenoma and who are not taking interfering steroids or oral estrogens are eligible.
✕Probably not a fit
People who are pregnant or breastfeeding, have known adrenal insufficiency, are taking systemic or topical steroids or other interfering drugs, or are under legal protection are not eligible and unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adrenal incidentalomas are common adrenal masses and about a third produce mild autonomous cortisol secretion (MACS), which is linked to higher metabolic and cardiovascular risk. This study will compare the short-term dynamics and rhythmicity of interstitial cortisol and other adrenal steroids in adults with MACS versus non-secreting adenomas using the U-RHYTHM sampling system. Microdialysis/continuous sampling will be performed every 20 minutes for 24 to 48 hours, with steroid assays on the collected perfusates to map hormone production over the day. Participants are adults with adrenal nodules who meet the specified cortisol and ACTH diagnostic thresholds and who are not taking interfering steroid medications or oral estrogens, and sampling will be performed at the hospital site.
Why it matters
Potential benefit: If successful, this approach could reveal temporal steroid abnormalities that improve diagnosis and understanding of MACS and help tailor patient management.
How similar studies have gone: A few small prior studies suggested late-afternoon or evening cortisol excess in MACS but were limited by infrequent sampling, and the high-resolution U-RHYTHM approach is relatively novel and untested at scale.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Hôpital Haut-Levêque
Pessac, France Recruiting
Study contacts
- Study coordinator: Amandine FERRIERE, Dr
- Email: amandine.ferriere@chu-bordeaux.fr
- Phone: 05 57 57 64 24
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.