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Recruiting

NCT Number: NCT04760522

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

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

WGS Diagnostic: Blood take for genetic diagnostic

Genetic

Blood sampling, short clinical characterization, WGS based sequencing, NGS analysis and other omics analysis (transcriptomics, proteomics, metabolomics).

Primary outcomes

  1. Number of WGS analysis

    Time frame: Day 1

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

Study contacts

Contact information is provided by the study sponsor or research team.

Andreas Dufke, PD Dr.

CONTACT

[email protected]

+49 7071 29 ext. 72190

Olaf Rieß, Prof. Dr.

CONTACT

[email protected]

+49 7071 29 ext. 72323

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Acronym: GE-MED

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Feb 18, 2021
Registry last updated
Nov 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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