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Recruiting Observational

New Clinical Decision Support Score Based on Steroid Hormone Profiling in the Diagnosis of MACS

NCT07352527 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2025-11-19
Last updated
2026-01-20

Condition(s) studied

Endocrine Disease

Study summary

The recent development of quantitative steroid metabolome profiling could be of interest for the positive diagnosis of mild autonomous cortisol-secreting adenoma (MACS). The aim of the study is to develop a predictive model of MACS status or non-secreting adenoma (NSA) based on a panel of 19 serum steroids and three clinico-biological parameters (body mass index or BMI, fasting glycaemia, blood pressure) and to estimate its performance for the diagnosis of MACS in a cohort of patients followed in the endocrinology department of Bordeaux University Hospital.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Assessment of the prediction model's performance — 18 months after inclusion
    Performance will be evaluated by internal validation using bootstrap sampling of 1,000 samples, and by the discrimination of the model by the ROC curve.

Trial sites (1)

FacilityCityRegionStatus
Hôpital du Haut-Lévêque Pessac France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07352527 on ClinicalTrials.gov ↗ ← All trials in France