New Clinical Decision Support Score Based on Steroid Hormone Profiling in the Diagnosis of MACS (NCT07352527) | Clinical Trial Compass
RecruitingNot Applicable
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 range
18 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.