RecruitingPHASE2INTERVENTIONAL

Exome Analysis (Complexe vs Simple) to Help the Therapeutic Decision for the Precision Medicine

This study, called EXOMA2, is exploring if a more detailed genetic test, called 'complex exome analysis,' can help doctors make better treatment decisions for people with advanced cancer. Currently, a 'simple exome analysis' looks at changes in a patient's genes. The complex analysis dives deeper, looking at other important genetic details that might influence how cancer behaves and responds to treatment. The main goal is to see if this advanced test provides new information that leads to different, potentially more effective, treatment choices for patients who are starting their first course of treatment for advanced or widespread cancer. Researchers want to know if these extra details can uncover treatment options that a simpler test might miss.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Centre Georges Francois Leclerc

Enrolment target

7,976

Start

25 Aug 2020

Estimated completion

02 Sep 2032

Cancer

What is this study about?

Imagine your body's instruction manual is made of genes. When you have cancer, some of these instructions get mixed up. Doctors can now look at these genetic changes to understand your cancer better and pick the best treatment for you. This is called 'precision medicine' because it's tailored to your unique cancer.

This study, called EXOMA2, is focusing on a special type of genetic test called 'exome analysis.' Think of your exome as the most important parts of your instruction manual. There are two ways to read this manual: a 'simple' way, which looks for the most obvious changes, and a 'complex' way, which digs much deeper into the details.

The researchers want to find out if the 'complex' analysis gives doctors vital extra information that could lead to new or better treatment choices that wouldn't have been found with the 'simple' analysis. They hope that by using this more detailed genetic roadmap, they can guide doctors to more effective treatments, especially for people who are just starting their first treatment for advanced cancer.

Key takeaways

This study compares basic and detailed genetic tests for advanced cancer.
It aims to see if detailed genetic information leads to better treatment choices.
It's for people starting their first treatment for advanced or widespread cancer.
You'll need to have some tumour tissue available for genetic testing.
The goal is to personalize cancer treatment more effectively.
You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with cancer that has spread or is advanced. You should be starting your very first treatment for this advanced cancer. You'll also need to have some of your tumour tissue available for the researchers to test.

There are also some general health requirements, such as weighing more than 30 kg and having a life expectancy of at least six months. You should also be able to follow all the study's instructions and be part of the UK social security system. Before joining, you'll need to understand everything about the study and agree to take part by signing a consent form.

You cannot join if your tumour tissue isn't available, or if you can't have a blood test. People who are pregnant, breastfeeding, or have certain infections like HIV, HBV, or HCV also can't take part. If you've been in a similar 'EXOMA' study before, you won't be able to join this one.

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.

Are you 18 years or older?
Do you have advanced or widespread cancer?
Are you about to start your first cancer treatment for this stage?
Is a sample of your tumour tissue available?
Do you feel well enough to participate in the study's procedures?
Are you able to provide consent and understand the study requirements?

Answer every question to see your result.

What does participation involve?

The detailed explanation of what taking part involves is not provided in the brief summary. To properly understand participation, you would need to speak with the study team. However, generally, studies like this would involve:

* **Initial Assessment:** This would include a review of your medical history, physical exams, and blood tests. * **Tissue Sample:** A sample of your tumour tissue would be needed for the exome analysis. This might be from a recent biopsy or a stored sample. * **Genetic Testing:** Your tumour tissue and potentially blood samples would be sent for special genetic tests (exome analysis). * **Treatment Decisions:** The study aims to see if the detailed genetic information helps guide your doctor's treatment decisions. Your doctor will discuss treatment options with you based on your individual case. * **Follow-up:** There would likely be appointments to monitor your health and how you respond to treatment, and to collect additional information for the study. The total duration of your participation would be explained by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that the more detailed genetic testing might provide new information that helps your doctor choose the best treatment for your cancer, possibly leading to better outcomes. However, there's no guarantee the study will lead to a new treatment plan for you. Risks might include discomfort or complications from blood tests or biopsies (if a new one is needed). There's also the chance the genetic analysis won't yield useful information. You are always free to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (12)

CHU Amiens Picardie
Verified postcode
Amiens, France· Not yet recruiting
CHRU Jean Minjoz
Verified postcode
Besançon, France· Recruiting
Institut Bergonie
Verified postcode
Bordeaux, France· Terminated
Centre Henri Baclesse
Verified postcode
Caen, France· Recruiting
CGFL
Verified postcode
Dijon, France· Recruiting
CHU François Mitterrand
Verified postcode
Dijon, France· Recruiting
Institut Hospitalier Franco-Britannique
Verified postcode
Levallois-Perret, France· Terminated
Centre Oscar Lambret
Verified postcode
Lille, France· Recruiting
CHU Nantes
Verified postcode
Nantes, France· Terminated
Chu Poitiers
Verified postcode
Poitiers, France· Terminated
Institut JeanGodinot
Verified postcode
Reims, France· Recruiting
Centre Eugène Marquis
Verified postcode
Rennes, France· Recruiting

Common questions

What is an exome analysis?

It's a special genetic test that looks at the most important parts of your DNA to find changes that might be linked to your cancer.

What is 'precision medicine'?

It's a way of treating cancer that uses detailed information about your genes and your specific cancer to choose the most effective treatments for you.

Why are there 'simple' and 'complex' analyses?

The study wants to see if a more detailed (complex) genetic test can give doctors more useful information than a basic (simple) test to help guide treatment.

Who is paying for this study?

The information provided does not state who is funding the study. You can ask the research team for this information.

Will I get my test results?

The study information doesn't say if you will directly receive your results. This is an important question to ask the study team if you're considering taking part.

How to find out more

François Ghiringhelli, PU-PH

fghiringhelli@cgfl.fr +33(0)3 80 73 75 00 Official trial record

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