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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Bordeaux

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

None

Trial 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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

291 Participants
are grouped into 3 trial groups
Group A: MACS group
Group B: ANS group
Group C: Control group

Trial outcomes

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.

Time frame
18 months after inclusion

Secondary outcomes

1

Correlation between blood steroid levels and blood pressure

The correlation between blood steroid levels and blood pressure will be evaluated in patients with MACS by correlating blood steroid concentrations and blood pressure thanks to ambulatory blood pressure monitoring which record 3 measurements during 3 consecutive days, and calculate after an average systolic and diastolic BP

Time frame
18 months after inclusion
2

Correlation between blood steroid levels and Body Mass Index

The correlation between blood steroid levels and Body Mass Index (BMI) will be evaluated in patients with MACS by correlating blood steroid concentrations obtain by dosages and calculated BMI (weight/size²).

Time frame
18 months after inclusion day
3

Correlation between blood steroid levels and carbohydrate tolerance

The correlation between blood steroid levels and carbohydrate tolerance will be evaluated in patients with MACS by correlating blood steroid concentrations and fasting blood glucose dosage, Hba1c, blood glucose levels 2 hours after glucose tolerance test.

Time frame
18 months after inclusoin day
4

Correlation between blood steroid levels and bone mineral density

The correlation between blood steroid levels and bone mineral density will be evaluated in patients with MACS by correlating blood steroid concentrations and bone mineral density thanks to bone densitometry.

Time frame
18 months after inclusion day

Other outcomes

Sponsors and contacts

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