Cushing s SyndromeCDE-AI-PatientNCT07916415
Automated Capture of Core Data for Rare Diseases and Glucocorticoid Complications: Biomarkers and Patient-Reported Outcomes
An observational study of Cushing s Syndrome and Glucocorticoid Effect, run by Assistance Publique - Hôpitaux de Paris at 3 sites in France.
Trial summary
Main goal: Looking for biological markers (molecular and biochemical) that predict glucocorticoid complications using blood and urine samples. Evaluation criterion: statistical association between biological markers and the occurrence of glucocorticoid complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cushing s Syndrome, Glucocorticoid Effect
- How many people
- 300 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Dec 2026to 1 Dec 2029
- 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: Adults with an excess of endogenous or exogenous glucocorticoids, managed in one of the three French rare disease networks FIRENDO, FILNEMUS, and FAI2R.
Who may be able to join
- Patient at least 18 years old
- Currently exposed to an excess of endogenous or exogenous glucocorticoids (corticosteroid therapy) for an estimated duration of at least 3 months
- Patient who has not opposed the research being conducted
- Patient affiliated with a French social security scheme or a beneficiary of such a scheme
Who cannot join
- Patients with a progressive malignant disease
- Pregnant or breastfeeding women
- Patients under guardianship or curatorship
- Patients under legal protection
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites
Hospices Civils de Lyon, Groupe hospitalier Est - Hôpital Femme Mère Enfant
Bron, 69500
Alexandre BELOT, +334 27 85 61 28, alexandre.belot@inserm.fr
Assistance publique Hôpitaux de Marseille (Hôpital de la Timone)
Marseille, 13385
Attarian SHARAM, +334 91 38 65 79, shahram.attarian@ap-hm.fr
Hôpital Cochin
Paris, 75014
Jérôme BERTHERAT, MD,PHD, 01 58 41 18 95, jerome.bertherat@aphp.fr
+33156095822
About this study
Official title: Automated Capture of Core Data Elements for Monitoring Rare Diseases and Glucocorticoid Complications: Biomarker Research and Patient-Reported Outcomes Assessment - CDE-AI-Patients
Main goal: Looking for biological markers (molecular and biochemical) that predict glucocorticoid complications using blood and urine samples.
Evaluation criterion: statistical association between biological markers and the occurrence of glucocorticoid complications.
Glucocorticoid-related complications are collected in a research program called "CDE.AI" (common data elements, artificial intelligence). CDE.AI aims at processing unstructured medical reports with natural language processing tools to fill in automatically forms reporting the outcome of patients with glucoocorticoid excess.
Read the detailed description
CDE.AI is initially aiming to build a form auto-fill tool using automatic language processing from unstructured medical reports, applied to monitoring the follow-up of rare diseases in France, with a specific focus on glucocorticoid complications (Glucocorticoids Complications-Core Data Elements, GC-CDE). Data from 10,000 patients will be processed. French regulations clearance was obtained for this part of the project, which falls under the reuse of health data.
The second part of the project aims to measure biomarkers in a sub-population of 300 patients to identify biomarkers associated with glucocorticoid complications and collect patient-reported outcomes, which constitutes research involving humans.
CDE.AI_patients is an ancillary part of the CDE.AI project that will look for biological markers (molecular and biochemical) associated with glucocorticoid-related complications. Patients will also fill in a form reflecting their perception of their disease, and their opinion on the use of AI-based tools to extract their clinical data. This prospective inclusion targets 300 patients.
- Conditions
- Cushing s Syndrome, Glucocorticoid Effect
- Keywords
- Exogenous glucocorticoid complications, Endogenous glucocorticoid complications
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 |
|---|---|---|
| Patients | Patients with glucocorticoid excess (endogenous or exogenous) |
What is being measured
The primary outcome is the main question the study is designed to answer.
biomarkers associated with glucocorticoid-excess complications
Association of molecular (whole blood transcriptome, DNA methylome, and DNA variants) and biochemical (mass spectrometry profiles from blood and urine) markers associated with glucocorticoid-induced complications
Measured: Single-spot assay (at inclusion) for biological samples.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cushing s SyndromeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France
- Responsible party
- Sponsor
- Investigators
- Guillaume ASSIE, MD, PhD, Study director, Assistance Publique - Hôpitaux de Paris (AP-HP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916415
- Sponsor's protocol ID
- APHP251481
- Other IDs
- 2025-A02873-46
- Acronym
- CDE-AI-Patient
- Status last verified
- Nov 2026
- First submitted
- 29 Oct 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated Capture of Core Data Elements for Monitoring Rare Diseases and Glucocorticoid Complications: Biomarker Research and Patient-Reported Outcomes Assessment - CDE-AI-Patients
- ClinicalTrials.gov ID
- NCT07916415
- Acronym / sponsor ID
- CDE-AI-Patient / APHP251481
- Conditions
- Cushing s Syndrome, Glucocorticoid Effect
- Keywords
- Exogenous glucocorticoid complications, Endogenous glucocorticoid complications
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- National Research Agency, France
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 4 Nov 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.
Main goal: Looking for biological markers (molecular and biochemical) that predict glucocorticoid complications using blood and urine samples.
Evaluation criterion: statistical association between biological markers and the occurrence of glucocorticoid complications.
Glucocorticoid-related complications are collected in a research program called "CDE.AI" (common data elements, artificial intelligence). CDE.AI aims at processing unstructured medical reports with natural language processing tools to fill in automatically forms reporting the outcome of patients with glucoocorticoid excess.
Detailed description
CDE.AI is initially aiming to build a form auto-fill tool using automatic language processing from unstructured medical reports, applied to monitoring the follow-up of rare diseases in France, with a specific focus on glucocorticoid complications (Glucocorticoids Complications-Core Data Elements, GC-CDE). Data from 10,000 patients will be processed. French regulations clearance was obtained for this part of the project, which falls under the reuse of health data.
The second part of the project aims to measure biomarkers in a sub-population of 300 patients to identify biomarkers associated with glucocorticoid complications and collect patient-reported outcomes, which constitutes research involving humans.
CDE.AI_patients is an ancillary part of the CDE.AI project that will look for biological markers (molecular and biochemical) associated with glucocorticoid-related complications. Patients will also fill in a form reflecting their perception of their disease, and their opinion on the use of AI-based tools to extract their clinical data. This prospective inclusion targets 300 patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients with glucocorticoid excess (endogenous or exogenous) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with an excess of endogenous or exogenous glucocorticoids, managed in one of the three French rare disease networks FIRENDO, FILNEMUS, and FAI2R.
Key inclusion criteria (4 listed)
- Patient at least 18 years old
- Currently exposed to an excess of endogenous or exogenous glucocorticoids (corticosteroid therapy) for an estimated duration of at least 3 months
- Patient who has not opposed the research being conducted
- Patient affiliated with a French social security scheme or a beneficiary of such a scheme
Key exclusion criteria (4 listed)
- Patients with a progressive malignant disease
- Pregnant or breastfeeding women
- Patients under guardianship or curatorship
- Patients under legal protection
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
biomarkers associated with glucocorticoid-excess complications
Time frame: Single-spot assay (at inclusion) for biological samples.
Association of molecular (whole blood transcriptome, DNA methylome, and DNA variants) and biochemical (mass spectrometry profiles from blood and urine) markers associated with glucocorticoid-induced complications
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 5 Nov 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Related trials for Cushing s Syndrome
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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.
Guillaume ASSIE, MD, PhD study director
Assistance Publique - Hôpitaux de Paris (AP-HP)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cushing s Syndrome and Glucocorticoid Effect, run by Assistance Publique - Hôpitaux de Paris at 3 sites 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 Guillaume ASSIE, MD, PhD (+33158411878, guillaume.assie@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biomarkers associated with glucocorticoid-excess complications (time frame: Single-spot assay (at inclusion) for biological samples.). 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 5 Nov 2026.