Genome-based Management of Patients in Precision Medicine (Ge-Med) Towards a Genomic Health Program

Rare Diseases Clinical Trial

— GE-MED  

Official title:

Genome-based Management of Patients in Precision Medicine (Ge-Med) Towards a Genomic Health Program

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04760522
• Other study ID #: GE-MED APPROACH
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Disease Susceptibility
• Genetic Predisposition to Disease
• Rare Diseases

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