Automated Capture of Core Data for Rare Diseases and Glucocorticoid Complications: Biomarkers and Patient-Reported Outcomes (CDE-AI-Patient)
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.
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Guillaume ASSIE, MD, PhD
- Telefonnummer: +33158411878
- E-mail: guillaume.assie@aphp.fr
Undersøgelse Kontakt Backup
- Navn: Malha BERRAH
- Telefonnummer: +33156095822
- E-mail: malha.berrah@aphp.fr
Studiesteder
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Bron, Frankrig, 69500
- Hospices Civils de Lyon, Groupe hospitalier Est - Hôpital Femme Mère Enfant
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Kontakt:
- Alexandre BELOT
- Telefonnummer: +334 27 85 61 28
- E-mail: alexandre.belot@inserm.fr
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Marseille, Frankrig, 13385
- Assistance publique Hôpitaux de Marseille (Hôpital de la Timone)
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Kontakt:
- Attarian SHARAM
- Telefonnummer: +334 91 38 65 79
- E-mail: shahram.attarian@ap-hm.fr
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Paris, Frankrig, 75014
- Hôpital Cochin
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Kontakt:
- Jérôme BERTHERAT, MD,PHD
- Telefonnummer: 01 58 41 18 95
- E-mail: jerome.bertherat@aphp.fr
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Kontakt:
- Telefonnummer: +33156095822
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Adults with an excess of endogenous or exogenous glucocorticoids, managed in one of the three French rare disease networks FIRENDO, FILNEMUS, and FAI2R.
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients with a progressive malignant disease
- Pregnant or breastfeeding women
- Patients under guardianship or curatorship
- Patients under legal protection
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: CROSS_SECTIONAL
Kohorter og interventioner
Gruppe / kohorte |
|---|
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Patients
Patients with glucocorticoid excess (endogenous or exogenous) |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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biomarkers associated with glucocorticoid-excess complications
Tidsramme: Single-spot assay (at inclusion) for biological samples.
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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 |
Single-spot assay (at inclusion) for biological samples.
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Studieleder: Guillaume ASSIE, MD, PhD, Assistance Publique - Hôpitaux de Paris (AP-HP)
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- APHP251481
- 2025-A02873-46 (Anden identifikator: ANSM)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
IPD-delingstidsramme
Two years after the last publication
IPD-delingsadgangskriterier
Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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