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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Guillaume ASSIE, MD, PhD
- 전화번호: +33158411878
- 이메일: guillaume.assie@aphp.fr
연구 연락처 백업
- 이름: Malha BERRAH
- 전화번호: +33156095822
- 이메일: malha.berrah@aphp.fr
연구 장소
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Bron, 프랑스, 69500
- Hospices Civils de Lyon, Groupe hospitalier Est - Hôpital Femme Mère Enfant
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연락하다:
- Alexandre BELOT
- 전화번호: +334 27 85 61 28
- 이메일: alexandre.belot@inserm.fr
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Marseille, 프랑스, 13385
- Assistance publique Hôpitaux de Marseille (Hôpital de la Timone)
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연락하다:
- Attarian SHARAM
- 전화번호: +334 91 38 65 79
- 이메일: shahram.attarian@ap-hm.fr
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Paris, 프랑스, 75014
- Hôpital Cochin
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연락하다:
- Jérôme BERTHERAT, MD,PHD
- 전화번호: 01 58 41 18 95
- 이메일: jerome.bertherat@aphp.fr
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연락하다:
- 전화번호: +33156095822
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Adults with an excess of endogenous or exogenous glucocorticoids, managed in one of the three French rare disease networks FIRENDO, FILNEMUS, and FAI2R.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: CROSS_SECTIONAL
코호트 및 개입
그룹/코호트 |
|---|
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Patients
Patients with glucocorticoid excess (endogenous or exogenous) |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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biomarkers associated with glucocorticoid-excess complications
기간: 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.
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공동 작업자 및 조사자
수사관
- 연구 책임자: Guillaume ASSIE, MD, PhD, Assistance Publique - Hôpitaux de Paris (AP-HP)
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- APHP251481
- 2025-A02873-46 (기타 식별자: ANSM)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
Two years after the last publication
IPD 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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