NCT07352527 New Clinical Decision Support Score Based on Steroid Hormone Profiling in the Diagnosis of MACS
| NCT ID | NCT07352527 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Bordeaux |
| Condition | Endocrine Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 291 participants |
| Start Date | 2025-11-19 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 291 participants in total. It began in 2025-11-19 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07352527 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Endocrine Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07352527 currently recruiting?
Yes, NCT07352527 is actively recruiting participants. Contact the research team at amandine.ferriere@chu-bordeaux.fr for enrollment information.
Where is the NCT07352527 trial being conducted?
This trial is being conducted at Pessac, France.
Who is sponsoring the NCT07352527 clinical trial?
NCT07352527 is sponsored by University Hospital, Bordeaux. The trial plans to enroll 291 participants.