Active not recruitingNAINTERVENTIONAL

RNASARC - Molecular Screening Program of Soft Tissue Sarcomas With Complex Genomic Profile to Detect NTRK1/2/3, ROS1 or ALK Gene Fusions.

This study is for people with advanced soft tissue sarcomas, a type of cancer that grows in the body's soft tissues. We are looking for specific gene changes (called NTRK, ROS1, or ALK gene fusions) within their tumour samples. These changes are important because they can help doctors decide which treatments might work best. If these gene changes are found, patients might be able to join another study testing a new cancer drug called entrectinib. We use special lab tests on tumour and blood samples to find these changes. This study aims to understand these gene changes better and help patients get access to more targeted treatments, if appropriate.

At a glance

Status

Active not recruiting

Phase

Sponsor

Centre Leon Berard

Enrolment target

376

Start

15 Feb 2018

Estimated completion

15 Dec 2025

Soft Tissue Sarcoma Advanced Cancer Metastatic Cancer

What is this study about?

This research study is looking at certain types of soft tissue sarcoma, which is a cancer that can affect many different parts of the body like muscle, fat, and nerves. When this cancer is advanced or has spread, doctors are always looking for the best ways to treat it. This study specifically aims to find out if certain gene changes, called NTRK1/2/3, ROS1, or ALK gene fusions, are present in these tumours.

Imagine your body's genes as an instruction manual. Sometimes, certain instructions can get mixed up or accidentally joined together – this is what we mean by 'gene fusions'. For some cancers, finding these particular 'mixed-up' instructions can be very important because it means certain medicines might work better. This study wants to see how often these specific gene fusions appear in soft tissue sarcomas that have a complicated genetic make-up.

The main goal is to identify patients who have these gene fusions. If found, these patients might then be suitable to join another clinical trial that is testing a drug called entrectinib, which is designed to target these specific gene changes. We also hope to learn more about how the immune system behaves in these tumours, which could help develop new treatments in the future.

Key takeaways

This study looks for specific gene changes in soft tissue sarcomas.
It helps identify patients who might benefit from targeted treatments.
Your tumour sample is key to this research.
Results could lead to opportunities for future clinical trials.
No new medicines are given in this screening study.
Participation is mainly about providing a tumour sample for testing.

Who may be eligible?

To join this study, you would need to be at least 12 years old and have been diagnosed with an advanced or metastatic soft tissue sarcoma that has a complex genetic profile. Examples include types like Leiomyosarcoma, Undifferentiated Pleomorphic Sarcoma, or Angiosarcoma.

We would also need to have a suitable tumour sample, usually from a previous biopsy or surgery, that was preserved. If not, a new biopsy might be needed. This sample must meet certain quality standards for the lab tests. You must also be able to understand and sign a consent form, and if you're under 18, a parent or legal guardian would also need to sign.

You would not be able to join if your tumour sample isn't suitable for testing, if you've already had treatments that target TRK, ROS1, or ALK pathways, or if you are pregnant or breastfeeding.

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 12 years old or older?
Do you have advanced or metastatic soft tissue sarcoma?
Do you have a tumour sample available, or could you have a new biopsy?
Have you *not* received certain targeted treatments (for TRK, ROS1, or ALK)?
Are you not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the main thing you would provide is a tumour sample. This can be an old sample from a previous surgery or biopsy, as long as it's less than three years old and preserved well. In some cases, if a suitable old sample isn't available, a new biopsy might be needed. We'll also collect some information about your overall health and medical history.

Your tumour sample will be sent to a special lab where it will be checked to make sure it's good enough for testing. If it is, the lab will perform special tests to look for the gene changes we're interested in (NTRK1/2/3, ROS1, or ALK gene fusions).

There are no additional clinic visits for this specific screening study beyond your usual care. The total duration of your active participation (providing the sample and initial checks) is short, but we will collect information about your health over time. If the gene changes are found, you might be invited to consider joining another treatment study.

Potential risks and benefits

The main benefit of this study is that it might identify specific gene changes in your tumour that could open the door to new treatment options, such as participating in another clinical trial with drugs like entrectinib. This screening process itself doesn't involve new medicines, so the risks are generally low. If a new biopsy is needed to get a tumour sample, it carries the usual small risks associated with such procedures, like bleeding or infection. You are always free to withdraw from the study at any time without affecting your medical care.

Locations (10)

Centre Jean Perrin
Verified postcode
Clermont-Ferrand, France
Centre Georges-Francois Leclerc
Verified postcode
Dijon, France
Centre Oscar Lambret
Verified postcode
Lille, France
CHU de Limoges Hôpital Dupuytren
Verified postcode
Limoges, France
Centre Léon Bérard
Verified postcode
Lyon, France
Institut de Cancérologie de Lorraine
Verified postcode
Nancy, France
Centre Antoine Lacassagne
Verified postcode
Nice, France
Institut Gustave ROUSSY
Verified postcode
Paris, France
Centre Eugène Marquis
Verified postcode
Rennes, France
Institut de Cancérologie de la Loire Lucien Neuwirth
Verified postcode
Saint-Priest-en-Jarez, France

Common questions

What is a 'soft tissue sarcoma'?

It's a type of cancer that forms in the body's soft tissues, like muscles, fat, blood vessels, nerves, and fibrous tissues.

What are gene fusions?

These are changes where parts of two different genes accidentally join together. Finding them can sometimes show which treatments might work best.

Will I receive new medicine in this study?

No, this study is a screening study. It aims to find specific gene changes. If found, you might be offered the chance to join a separate treatment study.

What happens if no gene fusions are found?

Your tumour sample will still be used to help us understand soft tissue sarcomas better, and we will continue to follow your health as part of the study.

Is a new biopsy always needed?

No, usually an existing tumour sample from a past surgery or biopsy can be used if it's recent enough and of good quality.