RecruitingNAINTERVENTIONAL

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

This study, called Ge-Med, is looking at how a detailed genetic test, Whole Genome Sequencing (WGS), can help doctors diagnose patients with rare diseases or conditions where genetics might play a role. Many people have illnesses where the exact cause isn't clear, and this study hopes to use WGS as a first-line test to get answers sooner. It will enroll about 12,000 patients whose disease cause isn't known or is suspected to be genetic. The goal is to make this advanced genetic testing a regular part of NHS care, helping to understand, predict, and prevent health problems more effectively. This could lead to more personalised care for many people in the UK.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital Tuebingen

Enrolment target

12,000

Start

01 Jun 2021

Estimated completion

01 Jul 2027

Rare Diseases Genetic Predisposition to Disease

What is this study about?

Imagine your body is like a very complex instruction manual. Sometimes, there's a typo or a missing page in that manual, which can lead to health problems or rare conditions. Doctors try to find these issues, but sometimes the cause isn't obvious.

This study, called Ge-Med, wants to use a very detailed genetic test, similar to reading your entire instruction manual cover-to-cover, to help figure out what’s going on. This test is called Whole Genome Sequencing (WGS). At the moment, WGS isn't always the first test doctors use. This project aims to see if making WGS a standard, early test can help diagnose conditions like rare diseases or certain types of cancer that run in families, much quicker and more effectively.

The main idea is to bring advanced genetic understanding directly into everyday hospital care. They are hoping to make healthcare more 'personalised' (meaning treatments are tailored just for you), 'predictive' (helping understand future health risks), and 'preventive' (taking steps to avoid problems). By doing this, they hope to get clear answers for patients sooner and guide doctors towards better care.

Key takeaways

It uses a detailed genetic test called Whole Genome Sequencing (WGS).
Aims to diagnose rare diseases and conditions with unclear causes.
Could make genetic testing a first step in diagnosis for some conditions.
Focuses on personalised, predictive, and preventive healthcare.
Participation involves providing a blood sample.
Could help find answers for previously undiagnosed conditions.

Who may be eligible?

This study is looking for a wide range of patients. You might be suitable if you have a health condition where doctors haven't been able to find the exact cause for your illness yet, or if they suspect your condition might be genetic.

However, you won't be able to join if you haven't given your permission (informed consent) to take part. Also, if you've already had a different type of detailed genetic test called Whole Exome Sequencing (WES) or a smaller 'panel' genetic test, you won't be eligible for this study, as they are trying to see if WGS works better as a first step.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do I have a health condition where the cause is currently unclear?
Do my doctors suspect my condition might be genetic?
Have I been asked if I would like to consider participating?
Have I NOT already had a Whole Exome Sequencing (WES) or 'panel' genetic test?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main thing you'll need to do is provide a blood sample. This blood sample will be used for the Whole Genome Sequencing (WGS) test. The study is a diagnostic one, meaning it's focused on finding answers about your condition, rather than testing a new medicine. There's no specific medication prescribed as part of this study, nor are there regular follow-up visits or assessments purely for the study beyond what your doctors would normally do for your care. The total duration of your direct involvement for providing the sample is very short, but the genetic analysis will take time, and results, if available and relevant, would be discussed by your clinical team in due course.

Potential risks and benefits

A potential benefit of joining this study is that Whole Genome Sequencing might provide a diagnosis for your condition that hasn't been found before, which could lead to more targeted care or better understanding for you and your family. The main risk involved is the minor discomfort and very small chance of bruising from the blood draw, which is a common medical procedure. There's also the possibility of uncertain results, where the genetic test doesn't provide a clear answer. You are completely free to withdraw from the study at any time without affecting your usual medical care.

Locations (1)

University Hospital Tübingen
Verified postcode
Tübingen, Germany· Recruiting

Common questions

What is Whole Genome Sequencing (WGS)?

WGS is a very detailed genetic test that reads almost all of your DNA, like scanning every page of your body's instruction manual to look for changes that might be causing health problems.

Will I get my results from this genetic test?

If the genetic test finds a clear answer for your condition, your doctors will discuss these results with you and explain what they mean for your care.

Is this study testing a new drug?

No, this study is not testing a new drug. It's looking at how a genetic test (WGS) can be used to help diagnose conditions more effectively.

How long does taking part in the study last?

Your direct involvement for the study, primarily providing a blood sample, is very short. The genetic analysis itself will take time, but you won't have extra appointments just for the study.

What if I change my mind after joining?

You are free to leave the study at any point, and your decision will not affect your ongoing medical care.

How to find out more

Olaf Rieß, Prof. Dr.

olaf.riess@med.uni-tuebingen.de +49 7071 29 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.