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

NCT07352527 | Recruiting

• 1 other identifier: CHUBX 2024/28
• Study Type: observational
• Target: 291
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Endocrine Disease

Keywords

Mild autonomous cortisol secreting adrenocortical adenoma; steroid hormone profiling; steroid metabolome; LC-MS/MS

Outcome Measures

Primary Outcomes (1)

• Assessment of the prediction model's performance

  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.

  18 months after inclusion

Secondary Outcomes (5)

• Correlation between blood steroid levels and blood pressure

  18 months after inclusion

• Correlation between blood steroid levels and Body Mass Index

  18 months after inclusion day

• Correlation between blood steroid levels and carbohydrate tolerance

  18 months after inclusoin day

• Correlation between blood steroid levels and bone mineral density

  18 months after inclusion day

• Correlation between blood steroid levels and bone architecture

  18 months after inclusion day

Study Arms (3)

MACS group

Mild autonomous cortisol-secreting adenoma group must at least have two elevated DST1mg (Cortisol \> 50 nmol/L or 1.8 µg/dL) and a plasma ACTH level ≤ 20 pg/mL

ANS group

Non-secreting adenoma must have a normal DST1mg (Cortisol ≤ 50 nmol/L or 1.8 µg/dL).

Control group

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The feasibility of the project is ensured by active and ongoing collaboration between: * The endocrinology department at Bordeaux University Hospital, which has recognized expertise in adrenal disorders, particularly MACS (participation in drafting European recommendations on adrenal incidentalomas, reference centers for rare adrenal diseases). It has strong potential for recruiting patients monitored for adrenal disorders throughout the Nouvelle-Aquitaine region. * The hormone department at Bordeaux University Hospital, itself a reference center for LC-MS/MS steroid dosing and active in research projects on this topic.

You may qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Hôpital du Haut-Lévêque

Pessac, 33604, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Endocrine System Diseases

Central Study Contacts

Amandine FERRIERE

CONTACT

05 57 57 64 24; amandine.ferriere@chu-bordeaux.fr

Julie Brossaud

CONTACT

05.57.82.15.01; julie.brossaud@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: January 20, 2026
• Study Start: November 19, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)