Genome-based Management of Patients in Precision Medicine (Ge-Med) Towards a Genomic Health Program
NCT ID: NCT04760522
Last Updated: 2023-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
12000 participants
INTERVENTIONAL
2021-06-01
2027-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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WGS Diagnostic
Both underage and adult persons (male and female) with diagnostically unsolved rare diseases who have been or are included into diagnostic care at the University Hospital Tübingen, Germany (UKT) and who are suspected of having a genetic cause of the disease.
Study related procedures: Blood sampling, anamnesis including pedigree, Next Generation Sequencing (NGS) analysis and other omics analysis (transcriptomics, proteomics, metabolomics).
WGS Diagnostic: Blood take for genetic diagnostic
Blood sampling, short clinical characterization, WGS based sequencing, NGS analysis and other omics analysis (transcriptomics, proteomics, metabolomics).
Interventions
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WGS Diagnostic: Blood take for genetic diagnostic
Blood sampling, short clinical characterization, WGS based sequencing, NGS analysis and other omics analysis (transcriptomics, proteomics, metabolomics).
Eligibility Criteria
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Inclusion Criteria
* Suspected genetic cause of the disease
Exclusion Criteria
* Previously performed WES or panel analysis
ALL
No
Sponsors
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University Hospital Tuebingen
OTHER
Responsible Party
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Principal Investigators
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Olaf Rieß, Prof. Dr.
Role: STUDY_DIRECTOR
University Hospital Tübingen
Locations
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University Hospital Tübingen
Tübingen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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GE-MED APPROACH
Identifier Type: -
Identifier Source: org_study_id