Genome-based Management of Patients in Precision Medicine (Ge-Med) Towards a Genomic Health Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity Hospital Tuebingen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Unclear molecular cause of the disease
Suspected genetic cause of the disease
Disqualifiers
Missing informed consent of the patient and if applicable the legal representative
Previously performed WES or panel analysis
Trial design
Design model
Single group
Treatments tested in this trial
WGS Diagnostic: Blood take for genetic diagnostic
GeneticBlood sampling, short clinical characterization, WGS based sequencing, NGS analysis and other omics analysis (transcriptomics, proteomics, metabolomics).
Treatment groups
12,000 Participants
are divided into 1 treatment groupGroup A: WGS DiagnosticExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of WGS analysis
WGS analysis as a first line diagnostic test for all clinical indications
Time frame
Day 1Sponsors and contacts
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Source ClinicalTrials.gov