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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04760522
Recruitment Status : Recruiting
First Posted : February 18, 2021
Last Update Posted : May 18, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

Brief 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.


Condition or disease Intervention/treatment Phase
Rare Diseases Genetic Predisposition to Disease Genetic: WGS Diagnostic: Blood take for genetic diagnostic Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12000 participants
Allocation: N/A
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rare Diseases

Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. Number of WGS analysis [ Time Frame: Day 1 ]
    WGS analysis as a first line diagnostic test for all clinical indications



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Olaf Rieß, Prof. Dr. +49 7071 29 ext 72323 olaf.riess@med.uni-tuebingen.de
Contact: Andreas Dufke, PD Dr. +49 7071 29 ext 72190 andreas.dufke@med.uni-tuebingen.de

Locations
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Germany
University Hospital Tübingen Recruiting
Tübingen, Germany, 72076
Contact: Olaf Rieß, Prof. Dr.    +49 7071 29 ext 72323    olaf.riess@med.uni-tuebingen.de   
Contact: Andreas Dufke, PD Dr.    +49 7071 29    andreas.dufke@med.uni-tuebingen.de   
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Study Director: Olaf Rieß, Prof. Dr. University Hospital Tübingen
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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT04760522    
Other Study ID Numbers: GE-MED APPROACH
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The GE-MED APPROACH study will provide data in a pseudonymized manner to national and international databases set up to increase the diagnostic yield through advanced analysis tools and matchmaking against other cohorts
Supporting Materials: Analytic Code
Time Frame: Data will become available after analysis and unlimited.
Access Criteria: Authorized users within the participating organizations.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Tuebingen:
Rare Diseases
Genetic Predisposition
Whole Exome Sequencing (WES)
Whole Genome Sequencing (WGS)
Familial cancer syndromes
Polygenic Risk Scores (PRS)
Additional relevant MeSH terms:
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Rare Diseases
Disease Susceptibility
Genetic Predisposition to Disease
Disease Attributes
Pathologic Processes