Steroid blood‑profile score to help diagnose mild autonomous cortisol‑secreting adrenal nodules (MACS)
New Clinical Decision Support Score Based on Steroid Hormone Profiling in the Diagnosis of Adrenal Adenomas With Moderate Autonomous Cortisol Secretion or MACS
University Hospital, Bordeaux · NCT07352527
This study will test if a single blood test measuring 19 steroid hormones plus basic clinical measures can distinguish people with mild autonomous cortisol secretion (MACS) from those with non‑secreting adrenal adenomas.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 291 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux (other) |
| Locations | 1 site (Pessac) |
| Trial ID | NCT07352527 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults with one or more adrenal nodules (≥1 cm or stable after ≥6 months) under evaluation for possible MACS who can give informed consent and are covered by a social security scheme are the intended candidates.
Not a fit: Patients with overt cortisol‑secreting Cushing’s syndrome, adrenal lesions with clear malignant features, or those unable to attend the Bordeaux site or provide required samples are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this could offer a more accurate single blood‑based tool to identify MACS and help guide clinical decision making without multiple separate hormone tests.
How similar studies have performed: LC‑MS/MS steroid profiling and steroidome approaches have shown promise in research for characterizing adrenal tumors, but predictive models specifically for MACS are relatively novel and need external validation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Pessac
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Endocrine Disease, Mild autonomous cortisol secreting adrenocortical adenoma, steroid hormone profiling, steroid metabolome, LC-MS/MS