Actively Recruiting
New Clinical Decision Support Score Based on Steroid Hormone Profiling in the Diagnosis of Adrenal Adenomas With Moderate Autonomous Cortisol Secretion or MACS
Led by University Hospital, Bordeaux · Updated on 2026-01-20
291
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new clinical decision support score based on steroid hormone profiling to improve the diagnosis of mild autonomous cortisol-secreting adenoma (MACS) versus non-secreting adrenal adenoma (NSA). This observational study focuses on using a panel of 19 serum steroids and three clinical parameters—body mass index (BMI), fasting blood sugar, and blood pressure—to develop a predictive model for MACS diagnosis in patients monitored at Bordeaux University Hospital. The study collects blood samples at inclusion during routine care, analyzing multiple steroids simultaneously using liquid chromatography-mass spectrometry (LC-MS/MS). It includes three groups: patients with MACS defined by specific cortisol and ACTH levels, patients with non-secreting adenomas, and a control group without adrenal pathology matched for age and sex. Clinical, biological, and imaging data are collected retrospectively over 24 months to develop and evaluate the model. Participants undergo blood tests, clinical evaluations, and imaging as part of their regular care throughout the study. Researchers will measure the model's performance 18 months after inclusion and assess correlations between blood steroid levels and blood pressure, BMI, carbohydrate tolerance, bone mineral density, and bone structure. The study spans up to 24 months, with all assays performed at Bordeaux University Hospital's hormonology laboratory.
CONDITIONS
Brief Title
New Clinical Decision Support Score Based on Steroid Hormone Profiling in the Diagnosis of MACS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- One or more unilateral or bilateral adrenal nodules with spontaneous density less than 20 HU on CT, size at least 1 cm, without overt hormone secretion
- Or adrenal nodules not meeting density criteria but stable in size after 6 months and no overt hormone secretion
- Written informed consent before any research examinations
- Affiliated to or covered by a social security scheme
- For MACS group: at least two elevated DST1mg cortisol tests and plasma ACTH level 20 pg/mL or less
- For ANS group: normal DST1mg cortisol test
- For control group: no known adrenal pathology, DST1mg test below 50 nmol/L, matched for age and sex to other groups
You will not qualify if you...
- Adrenal incidentaloma smaller than 1 cm
- Use of systemic or local corticosteroids in the 6 months before the trial
- Use of drugs that affect dexamethasone metabolism
- Pregnant women
- Life-threatening conditions
- Active illness at time of blood sampling (e.g., fever, COVID, influenza)
- Urinary free cortisol above normal laboratory limits
- Patients under legal protection or court guardianship
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for blood sampling and eligibility assessment
Duration - 24 months
Participants are observed over a 24-month period with clinical, biological, and morphological data collected as part of routine care.
Data collected retrospectively from routine care visits
Trial Site Locations
Total: 1 location
1
Hôpital du Haut-Lévêque
Pessac, France, 33604
Actively Recruiting
Research Team
A
Amandine FERRIERE
J
Julie Brossaud
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here