Endocrine DiseaseMACSCORENCT07352527
New Clinical Decision Support Score Based on Steroid Hormone Profiling in the Diagnosis of MACS
An observational study of Endocrine Disease, run by University Hospital, Bordeaux at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endocrine Disease
- How many people
- 291 participants
- Where
- 1 siteFrance
- Study dates
- 19 Nov 2025to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Show all 23Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital du Haut-Lévêque
Pessac, 33604
Amandine FERRIERE, Dr, 05 57 57 64 24 ext. +33, amandine.ferriere@chu-bordeaux.fr
About this study
Official title: New Clinical Decision Support Score Based on Steroid Hormone Profiling in the Diagnosis of Adrenal Adenomas With Moderate Autonomous Cortisol Secretion or MACS
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.
Read the detailed description
Steroid assays are a central element in the aetiological diagnosis of adrenal tumors, but they are still limited to single assays (e.g. cortisol in Cushing's syndrome, aldosterone in primary hyperaldosteronism, etc.) which only partially reflect the endocrine disturbances caused by adrenal pathologies. The recent development of quantitative profiling of the circulating steroidome could lead to a reconsideration of the role of these single steroid assays in endocrinology. This involves simultaneously measuring of multiple steroids from a single blood or urine sample using liquid chromatography-mass spectrometry (LC-MS/MS). The steroid fingerprint obtained enables adrenal masses to be better characterised. Using machine learning methods, a predictive model of MACS status or NSA based on a panel of 19 serum steroids measured by LC-MS/MS and three clinico-biological parameters (body mass index or BMI, fasting glycaemia, blood pressure) will be develop. The blood sample used for the steroid assay will be taken at inclusion during a blood test carried out as part of routine care. Clinical, biological and morphological data obtained during the 24 months of study follow-up and as part of routine care will be collected retrospectively. All assays will be carried out in the hormonology laboratory of Bordeaux University Hospital (BUH) by LC-MS/MS. The development of the MACS/ANS status prediction model will be carried out by the BUH Methodological Support Unit for Clinical and Epidemiological Research (USMR). The performance and prognostic value of this new tool will be estimated in a cohort of patients followed in the BUH endocrinology department.
- Conditions
- Endocrine Disease
- Keywords
- Mild autonomous cortisol secreting adrenocortical adenoma, steroid hormone profiling, steroid metabolome, LC-MS/MS
- Medical subject headings
- Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 18 months after inclusion
Secondary outcomes (5)
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
Measured: 18 months after inclusion
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).
Measured: 18 months after inclusion day
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.
Measured: 18 months after inclusoin day
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.
Measured: 18 months after inclusion day
Correlation between blood steroid levels and bone architecture
The correlation between blood steroid levels and bone architecture will be evaluated in patients with MACS by correlating blood steroid concentrations and bone architecture thanks to Trabecular Bone Score (TBS).
Measured: 18 months after inclusion day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start19 Nov 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocrine DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 291 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352527
- Sponsor's protocol ID
- CHUBX 2024/28
- Acronym
- MACSCORE
- Status last verified
- Jan 2026
- First submitted
- 16 Sep 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Clinical Decision Support Score Based on Steroid Hormone Profiling in the Diagnosis of Adrenal Adenomas With Moderate Autonomous Cortisol Secretion or MACS
- ClinicalTrials.gov ID
- NCT07352527
- Acronym / sponsor ID
- MACSCORE / CHUBX 2024/28
- Conditions
- Endocrine Disease
- Keywords
- Mild autonomous cortisol secreting adrenocortical adenoma, steroid hormone profiling, steroid metabolome, LC-MS/MS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 291 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Steroid assays are a central element in the aetiological diagnosis of adrenal tumors, but they are still limited to single assays (e.g. cortisol in Cushing's syndrome, aldosterone in primary hyperaldosteronism, etc.) which only partially reflect the endocrine disturbances caused by adrenal pathologies. The recent development of quantitative profiling of the circulating steroidome could lead to a reconsideration of the role of these single steroid assays in endocrinology. This involves simultaneously measuring of multiple steroids from a single blood or urine sample using liquid chromatography-mass spectrometry (LC-MS/MS). The steroid fingerprint obtained enables adrenal masses to be better characterised. Using machine learning methods, a predictive model of MACS status or NSA based on a panel of 19 serum steroids measured by LC-MS/MS and three clinico-biological parameters (body mass index or BMI, fasting glycaemia, blood pressure) will be develop. The blood sample used for the steroid assay will be taken at inclusion during a blood test carried out as part of routine care. Clinical, biological and morphological data obtained during the 24 months of study follow-up and as part of routine care will be collected retrospectively. All assays will be carried out in the hormonology laboratory of Bordeaux University Hospital (BUH) by LC-MS/MS. The development of the MACS/ANS status prediction model will be carried out by the BUH Methodological Support Unit for Clinical and Epidemiological Research (USMR). The performance and prognostic value of this new tool will be estimated in a cohort of patients followed in the BUH endocrinology department.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (23 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of the prediction model's performance
Time frame: 18 months after inclusion
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.
5 secondary outcomes
Correlation between blood steroid levels and blood pressure
Time frame: 18 months after inclusion
Correlation between blood steroid levels and Body Mass Index
Time frame: 18 months after inclusion day
Correlation between blood steroid levels and carbohydrate tolerance
Time frame: 18 months after inclusoin day
Correlation between blood steroid levels and bone mineral density
Time frame: 18 months after inclusion day
Correlation between blood steroid levels and bone architecture
Time frame: 18 months after inclusion day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endocrine Disease, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amandine FERRIERE (05 57 57 64 24 ext. +33, amandine.ferriere@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the prediction model's performance (time frame: 18 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.