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Clinical Trials/NCT04760522
NCT04760522
Recruiting
Not Applicable

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

University Hospital Tuebingen1 site in 1 country12,000 target enrollmentJune 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rare Diseases
Sponsor
University Hospital Tuebingen
Enrollment
12000
Locations
1
Primary Endpoint
Number of WGS analysis
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2021
End Date
July 2027
Last Updated
2 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Number of WGS analysis

Time Frame: Day 1

WGS analysis as a first line diagnostic test for all clinical indications

Study Sites (1)

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