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Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

MULTISARC : MOLECULAR PROFILING OF ADVANCED SOFT-TISSUE SARCOMAS. A phase III study

This study, called MULTISARC, is for people with advanced soft tissue sarcoma that cannot be removed by surgery or has spread. Researchers are trying to discover if a special test, called 'next-generation sequencing exome' (NGS), can quickly find specific changes in a patient’s cancer cells. This test aims to help doctors choose the most effective treatment for each individual from a range of new medications. The main goal is to see if these tests can be done within 7 weeks and provide clear recommendations. The study also looks at how long people live, how long they stay well without their cancer getting worse, and how their bodies respond to the treatments.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic confirmatory (Phase III)
Sponsor
Institut National De La Sante Et De La Recherche Medicale
Enrolment target
960
Start
03 Oct 2024

What is this study about?

This study, called MULTISARC, is looking for better ways to treat advanced soft tissue sarcoma. This is a type of cancer that grows in the body's soft tissues, like muscle, fat, or blood vessels. 'Advanced' means the cancer is either too big to remove with surgery in the area where it started, or it has spread to other parts of the body. Treatment for this kind of cancer can be challenging, and doctors are always looking for more effective and personalised options.

The main idea behind MULTISARC is to use a special test to look at the unique genetic makeup of each person's cancer cells. This test, called 'next-generation sequencing exome,' helps to find tiny changes in the cancer's DNA. These changes can sometimes act like a code that tells doctors which specific medicines might work best to fight that particular cancer. Think of it like unlocking a puzzle – finding the right key (the medicine) for your unique lock (your cancer).

Researchers want to see if this special testing process can be done quickly and practically. They aim for the results and a recommended treatment plan to be ready within 7 weeks of receiving blood and tumour samples. In simpler terms, they want to make sure this personalised approach is efficient enough to help patients without too much delay. The study also carefully tracks how well people respond to treatment, how long they live, and how long they live without their cancer getting worse, to understand the benefits of this approach.

Key takeaways

  • Targets advanced soft-tissue sarcoma that cannot be surgically removed or has spread.
  • Uses advanced genetic testing to find a personalised treatment for each patient.
  • Aims to process test results and provide treatment recommendations within 7 weeks.
  • Involves a range of new medications, some currently in development.
  • Monitors how long people live and how long their cancer stays stable.
  • Open to adults aged 18 and over, regardless of gender.

Who may be eligible?

This study is designed for adults, meaning you must be 18 years old or older. There is no upper age limit, so people of any adult age can take part.

It is specifically for individuals diagnosed with advanced soft-tissue sarcoma. This means your cancer cannot be removed by surgery in its current location, or it has spread to other parts of your body.

Both men and women can participate in this study. The medical team will check other health details to make sure the study is a safe and suitable option for you.

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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with advanced soft-tissue sarcoma?
  3. Is your sarcoma unable to be removed by surgery or has it spread?
  4. Are you able to provide blood and tumour samples?
Answer every question to see your result.

What does participation involve?

If you join this study, the first step involves providing blood and tumour samples. These samples will be sent for a special 'next-generation sequencing exome' test. This test looks closely at your cancer cells to find specific changes that might help doctors choose the best medicine for you. The aim is to get these results and a treatment recommendation from a group of experts within 7 weeks.

Based on these results, your doctors might suggest a specific targeted treatment from a list of available medicines. You would then start taking this medication, which could be in tablet form or as an infusion (given through a drip). You will have regular visits to monitor your health, how you're responding to the treatment, and to check for any side effects. The specific number of visits and tests will depend on the treatment you receive and how you are doing. The exact total duration of your participation will vary, depending on how your treatment progresses and the follow-up required after the main treatment phase.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as gaining access to new treatments that are not yet widely available and receiving specialised care. The personalised approach aims to find the most suitable medicine for your specific cancer, which could lead to better outcomes. However, as with any medical treatment, there are potential risks and side effects associated with the study medications. These can vary greatly depending on the specific drug you receive, and the study team will explain these thoroughly. You will always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    France

Common questions

What is soft tissue sarcoma?

It's a rare cancer that starts in the body's soft tissues, like muscle, fat, nerves, or blood vessels.

What does 'advanced' cancer mean in this study?

It means the cancer can't be removed by surgery in its current spot, or it has spread to other parts of your body.

What is 'next-generation sequencing'?

It's a special test that examines the genetic code of your cancer cells to find changes that might help choose the best medicine.

Will I definitely get a new treatment if I join?

The study aims to identify if a suitable new treatment can be matched to your cancer based on test results, but it's not guaranteed.

Can I stop participating in the study if I change my mind?

Yes, you can leave the study at any time without it affecting your regular medical care.

How to find out more

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

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