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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04760522
Other study ID # GE-MED APPROACH
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2021
Est. completion date July 2027

Study information

Verified date November 2023
Source University Hospital Tuebingen
Contact Olaf Rieß, Prof. Dr.
Phone +49 7071 29
Email olaf.riess@med.uni-tuebingen.de
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 12000
Est. completion date July 2027
Est. primary completion date July 2026
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
Germany University Hospital Tübingen Tübingen

Sponsors (1)

Lead Sponsor Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of WGS analysis WGS analysis as a first line diagnostic test for all clinical indications Day 1
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