Steroid blood‑profile score to help diagnose mild autonomous cortisol‑secreting adrenal nodules (MACS)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will collect a blood sample at inclusion from patients with adrenal nodules followed at Bordeaux University Hospital and measure a panel of 19 serum steroids by LC‑MS/MS. They will combine these steroid levels with three clinical/biological variables (BMI, fasting glycaemia, and blood pressure) and use machine‑learning methods to develop a predictive model separating MACS from non‑secreting adenomas. Clinical, biological and imaging data from routine care over 24 months will be gathered retrospectively to support model development. All steroid assays will be performed in the hormonology laboratory at Bordeaux University Hospital.

Why it matters

Who can join: the full rules

Inclusion Criteria:

MACS and ANS group:

* 18 years ≤ Age
* Patient with one or more unilateral or bilateral adrenal nodules with spontaneous density \< 20 HU on CT and major axis ≥ 1 cm and without associated overt pathological hormonal secretion.
* Patient with one or more uni or bilateral adrenal nodules not meeting the above density criteria but without malignancy criteria and stable in size on imaging after at least 6 months of follow-up and without associated overt pathological hormone secretion.
* Written consent of the patient for his participation in the research (at the latest on the day of inclusion and before any examination required by the research).
* Subject affiliated to or benefiting from a social security scheme.

Diagnostic criteria (determined after blood sampling) for continuation of the study:

MACS group:

* At least two elevated DST1mg (Cortisol \> 50 nmol/L or 1.8 µg/dL) AND
* a plasma ACTH level ≤ 20 pg/mL

ANS group:

\- Normal DST1mg (Cortisol ≤ 50 nmol/L or 1.8 µg/dL). The definition criteria for MACS and ANS were based on the latest recommandations of learned societies.

Controls group:

* patients followed in the endocrinology department, free of any known adrenal pathology and with a DST1mg test \< 50nmol/L.
* matched for age and sex to patients in groups 1 and 2.

Non -inclusion criteria:

* Adrenal incidentaloma \< 1 cm in size.
* Use of exogenous corticosteroids, whether systemic or local (inhaled, eye and ear drops, ophthalmic ointment, topical skin products, joint infiltration) in the 6 months prior to the trial, and drugs that interfere with the metabolism of dexamethasone.
* Pregnant women.
* Patients with any other life-threatening condition.
* Patients with an intercurrent pathology at the time of blood sampling (fever, COVID infection, influenza....).
* Urinary free cortisol (UFC) \> at the limit of laboratory normality.
* Patients under court protection.

Where it's running

• Hôpital du Haut-Lévêque
  Pessac, France Recruiting

Study contacts

• Study coordinator: Amandine FERRIERE
• Email: amandine.ferriere@chu-bordeaux.fr
• Phone: 05 57 57 64 24

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.