Genome-based Management of Patients in Precision Medicine (Ge-Med) Towards a Genomic Health Program (GE-MED)
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|ClinicalTrials.gov Identifier: NCT04760522|
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : May 18, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Rare Diseases Genetic Predisposition to Disease||Genetic: WGS Diagnostic: Blood take for genetic diagnostic||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Genome-based Management of Patients in Precision Medicine (Ge-Med) Towards a Genomic Health Program|
|Actual Study Start Date :||June 1, 2021|
|Estimated Primary Completion Date :||July 2026|
|Estimated Study Completion Date :||July 2027|
Experimental: 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).
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).
- Number of WGS analysis [ Time Frame: Day 1 ]WGS analysis as a first line diagnostic test for all clinical indications
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04760522
|Contact: Olaf Rieß, Prof. Dr.||+49 7071 29 ext email@example.com|
|Contact: Andreas Dufke, PD Dr.||+49 7071 29 ext firstname.lastname@example.org|
|Study Director:||Olaf Rieß, Prof. Dr.||University Hospital Tübingen|