RecruitingNCT07352527

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

New Clinical Decision Support Score Based on Steroid Hormone Profiling in the Diagnosis of Adrenal Adenomas With Moderate Autonomous Cortisol Secretion or MACS

Sponsor

University Hospital, Bordeaux

Enrollment

291 participants

Start Date

Nov 19, 2025

Study Type

OBSERVATIONAL

Conditions

Endocrine Disease

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

Min Age: 18 Years

Inclusion Criteria22

MACS and ANS group:
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.
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.