APPROACH Cohort
Applied Public-Private Research enabling OsteoArthritis Clinical Headway
groups: IMI Projects
tags: IMI Translational Medicine
- First Name
- Andreas
- Last Name
- Tielmann
- Affiliation
- Merck KGaA
- Andreas.Tielmann@merckgroup.com
- Business Phone Number
- 6151722909
- Business Fax Number
- -
- Business Address
- Merck KGaA | Frankfurter Str. 250 | 64293 Darmstadt | Germany
- Project Website
- http://www.approachproject.eu/
- Version
- V0
- Date of creation of the dataset
- 2017-01-25
- Date of the last update of the dataset
- 2021-12-01
- Funding
- IMI
- Reference Publications
- http://approachproject.eu/news-events/approach-project-receives-15-million-euro-research-funding
- Data Standards Implemented
- CDISK
- Therapeutic Area Standards (Disease Area)
- Osteoarthritis
- Study Protocal Description
- All baseline cohort parameters, clinical, conventional (knee x-ray and MRI and the robust biochemical markers), and novel markers (T2 relaxation MRI for cartilage collagen distribution, gagCEST MRIcartilage for proteoglycan content, knee CT/x-ray for bone shape and trabecular architecture, knee motion, and novel biochemical markers describing turnover of specific tissue component, as well as involvement of hand, hip and spine joint damage, hand joint inflammation, hip motion and shape and bone architecture) will be used to identify (a set of) predictors that can discriminate between the knee OA progressors and (paired) non-progressors within a specific phenotype.
- Multi-center Study
- True
- Description of Cohorts
- -
- Study Type
- OBSERVATIONAL
- Study Type Comment
- -
- Primary Purpose
- Define subsets of (phenotypically) different patients in both the existing cohorts as well as (later) in the new longitudinal extension cohorts and subsequently identify the “right patient” to treat for each subset/phenotype via innovative stratification techniques.
- Study Phase
- selection criteria
- Intervention Model
- -
- Study Classification
- Biomarker Validation and Qualification
- Indication
- knee osteoarthritis
- Age Range (Low Limit) of Study
- -
- Age Range (Upper Limit) of Study
- -
- Age Unit (of the above ranges)
- -
- BMI Range
- -
- BMI Range (lower limit)
- -
- BMI Range (upper limit)
- -
- Informed Consent
- True
- Planned Arm (Description of Sub-cohorts)
- cohort will also include age-matched healthy controls as well as end-stage established OA patients assigned to ‘dominant’ progressive subclasses of clinically defined knee osteoarthritis with potential involvement of hip and/or hand OA with each a paired non-progressive knee OA phenotype
- Name of Treatment
- -
- Standardized Name of Treatment
- -
- Category
- -
- Dose Description
- -
- Organism
- Homo sapiens
- Body System or Organ Class
- -
- Total Number of (Human) Subjects
- 1000
- Total Number of (Non-Human) Subjects
- 1000
- Number of Subjects in Each Cohorts (if multi-cohorts)
- -
- Detail Subject Composition
- -
- Type of Samples Collected
- Blood Serum
- Number of Samples Collected
- -
- Samples Details
- -
- Secondary Analysis
- Genomics variant array, Transcriptome array, Clinical imaging, Proteomics