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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Guillaume ASSIE, MD, PhD
- 电话号码：+33158411878
- 邮箱：guillaume.assie@aphp.fr
研究联系人备份
- 姓名：Malha BERRAH
- 电话号码：+33156095822
- 邮箱：malha.berrah@aphp.fr
学习地点
-
-
-
Bron、法国、69500
- Hospices Civils de Lyon, Groupe hospitalier Est - Hôpital Femme Mère Enfant
-
接触：
- Alexandre BELOT
- 电话号码：+334 27 85 61 28
- 邮箱：alexandre.belot@inserm.fr
-
Marseille、法国、13385
- Assistance publique Hôpitaux de Marseille (Hôpital de la Timone)
-
接触：
- Attarian SHARAM
- 电话号码：+334 91 38 65 79
- 邮箱：shahram.attarian@ap-hm.fr
-
Paris、法国、75014
- Hôpital Cochin
-
接触：
- Jérôme BERTHERAT, MD,PHD
- 电话号码：01 58 41 18 95
- 邮箱：jerome.bertherat@aphp.fr
-
接触：
- 电话号码：+33156095822
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Adults with an excess of endogenous or exogenous glucocorticoids, managed in one of the three French rare disease networks FIRENDO, FILNEMUS, and FAI2R.
描述
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
学习计划
研究是如何设计的？
设计细节
- 观测模型：COHORT
- 时间观点：CROSS_SECTIONAL
队列和干预
团体/队列 |
|---|
|
Patients
Patients with glucocorticoid excess (endogenous or exogenous) |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
biomarkers associated with glucocorticoid-excess complications
大体时间：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.
|
合作者和调查者
调查人员
- 研究主任：Guillaume ASSIE, MD, PhD、Assistance Publique - Hôpitaux de Paris (AP-HP)
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- APHP251481
- 2025-A02873-46 (其他标识符：ANSM)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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 共享时间框架
Two years after the last publication
IPD 共享访问标准
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 共享支持信息类型
- 研究方案
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.