New Clinical Decision Support Score Based on Steroid Hormone Profiling in the Diagnosis of MACS (NCT07352527) | Clinical Trial Compass
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New Clinical Decision Support Score Based on Steroid Hormone Profiling in the Diagnosis of MACS
France291 participantsStarted 2025-11-19
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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, to…