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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Guillaume ASSIE, MD, PhD
- 電話番号：+33158411878
- メール：guillaume.assie@aphp.fr
研究連絡先のバックアップ
- 名前：Malha BERRAH
- 電話番号：+33156095822
- メール：malha.berrah@aphp.fr
研究場所
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Bron、フランス、69500
- Hospices Civils de Lyon, Groupe hospitalier Est - Hôpital Femme Mère Enfant
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コンタクト：
- Alexandre BELOT
- 電話番号：+334 27 85 61 28
- メール：alexandre.belot@inserm.fr
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Marseille、フランス、13385
- Assistance publique Hôpitaux de Marseille (Hôpital de la Timone)
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コンタクト：
- Attarian SHARAM
- 電話番号：+334 91 38 65 79
- メール：shahram.attarian@ap-hm.fr
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Paris、フランス、75014
- Hôpital Cochin
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コンタクト：
- Jérôme BERTHERAT, MD,PHD
- 電話番号：01 58 41 18 95
- メール：jerome.bertherat@aphp.fr
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コンタクト：
- 電話番号：+33156095822
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Adults with an excess of endogenous or exogenous glucocorticoids, managed in one of the three French rare disease networks FIRENDO, FILNEMUS, and FAI2R.
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：CROSS_SECTIONAL
コホートと介入
グループ/コホート |
|---|
|
Patients
Patients with glucocorticoid excess (endogenous or exogenous) |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
biomarkers associated with glucocorticoid-excess complications
時間枠：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 |
Single-spot assay (at inclusion) for biological samples.
|
協力者と研究者
捜査官
- スタディディレクター：Guillaume ASSIE, MD, PhD、Assistance Publique - Hôpitaux de Paris (AP-HP)
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- APHP251481
- 2025-A02873-46 (その他の識別子：ANSM)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
Two years after the last publication
IPD 共有アクセス基準
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 共有サポート情報タイプ
- STUDY_PROTOCOL
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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