Genome-based Management of Patients in Precision Medicine (Ge-Med) Towards a Genomic Health Program
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: WGS Diagnostic: Blood take for genetic diagnostic.
- Who it may be relevant to
- Registry conditions: Rare Diseases, Genetic Predisposition to Disease. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The GE-MED APPROACH project will enroll patients (n = appr. 12.000) with unclear molecular cause of the disease, suspected genetic cause of the disease without detailed molecular analysis like Whole Exome Sequencing (WES). The novelty of this study is to integrate genomic health concepts into immediate clinical care. To achieve these goals, a novel structure for the Triple P (3P) concept of personalized medicine (Personalized, Predictive, Preventive) integrated into a well-established health care system and associated with novel decentralized Disease Analysing Task Forces (DATF) will be implemented. The overall goal of this study is to implement, for the first time, Whole Genome Sequencing (WGS) analysis as a first line diagnostic test for all clinical indications such as Rare Disease (RD )and familial cancer syndromes.
Interventions
- Genetic WGS Diagnostic: Blood take for genetic diagnostic
Blood sampling, short clinical characterization, WGS based sequencing, NGS analysis and other omics analysis (transcriptomics, proteomics, metabolomics).
Primary outcome measures
- Number of WGS analysis [Time frame: Day 1]
Eligibility criteria
Inclusion criteria
- Unclear molecular cause of the disease
- Suspected genetic cause of the disease
Exclusion criteria
- Missing informed consent of the patient and if applicable the legal representative
- Previously performed WES or panel analysis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Germany · 1 center
- University Hospital Tübingen — Tübingen
Identifiers
NCT: NCT04760522 · GE-MED APPROACH