RecruitingNAINTERVENTIONAL

Integrative Molecular Analysis of Individual Radiosensitivity in Pediatric Oncology

This study aims to understand how individual children with cancer respond to radiotherapy. By carefully examining blood samples, researchers hope to discover why some young patients might be more sensitive to radiation treatment than others. This isn't a new treatment trial; instead, it's about gathering important information to help make future radiotherapy safer and more effective, reducing potential side effects. The study includes children and teenagers aged 3 to 18 who are having radiotherapy for certain types of cancer, such as brain tumours or Hodgkin's lymphoma. The goal is to improve our understanding of radiation's effects at a very detailed level, which could eventually lead to more personalised care for young cancer patients.

At a glance

Status

Recruiting

Phase

Sponsor

Neolys

Enrolment target

100

Start

02 Dec 2023

Estimated completion

30 Oct 2027

Radiosensitivity Pediatric Cancer Radiation Toxicity

What is this study about?

This research study is focused on children and young people who are receiving radiotherapy for cancer. Radiotherapy is a very important treatment that uses high-energy rays to kill cancer cells. While it's very effective, it can also affect healthy cells, and sometimes people react differently to the treatment.

The main aim of this study is to look at your individual 'radiosensitivity'. This big word simply means how sensitive your body is to the radiation treatment. The researchers want to understand why some young patients might experience more side effects or react differently to radiotherapy than others. This isn't about giving you a new treatment; it's about collecting information to help us learn more.

By taking a simple blood sample, scientists can look closely at your cells to find clues about your unique sensitivity. The hope is that by understanding these differences, doctors might one day be able to give more tailored and safer radiotherapy treatments to children and young people, reducing unwanted side effects and making sure the treatment is as effective as possible.

Key takeaways

This study helps understand why children react differently to radiotherapy.
It involves giving a single blood sample, usually during a routine hospital visit.
The study aims to make future radiotherapy safer and more tailored for young patients.
Your cancer treatment will not change if you take part.
You can stop participating at any time without affecting your care.

Who may be eligible?

This study is looking for children and teenagers between 3 and 18 years old who are currently being treated for certain types of cancer with radiotherapy. This includes cancers like brain tumours, specific bone cancers (Ewing tumor, malignant mesenchymal tumor), neuroblastoma, kidney cancer (nephroblastoma), and Hodgkin's lymphoma. You must be having radiotherapy as part of your main treatment to cure your cancer, not just to relieve symptoms, and your doctor must have planned standard radiotherapy doses (about 1.8 to 2.2 Gy per session, 5 times a week).

There are also a few important things that would mean you couldn't join the study. For example, if you can't have blood samples taken for any reason, or if you can't have radiotherapy. If your radiotherapy is just for comfort (palliative care), or if you've already had radiotherapy in the same area before, you won't be able to take part. Also, if your planned radiotherapy uses a different schedule (called hypofractionated RT), or if doctors won't be able to keep in touch with you for follow-up, you wouldn't be suitable.

Finally, for you to take part, you (or your parents/guardians, if you are under 16) would need to fully understand the study and agree to participate by signing a consent form. You also need to be part of a social security scheme, which covers things like healthcare in the UK.

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 between 3 and 18 years old?
Are you having radiotherapy for a brain tumour, Ewing tumor, malignant mesenchymal tumor, neuroblastoma, nephroblastoma, or Hodgkin's lymphoma?
Is your radiotherapy being given to try and cure your cancer?
Are you able to have a blood sample taken?
Have you or your parents/guardians understood and agreed to sign a consent form?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the main thing you would need to do is provide a blood sample. This would be taken at a convenient time, possibly during one of your routine hospital visits, so it shouldn't add extra trips for you. There are no special medications to take or extra treatments involved in this study. The researchers will simply use the blood sample to learn more about how your body responds to radiotherapy. You would continue to receive your cancer treatment as planned by your doctors, and this study would not change your treatment plan. The study itself doesn't involve long-term follow-up beyond providing the blood sample and letting researchers access some of your treatment information. The total duration of your active involvement would be very short, just for the blood sample collection.

Potential risks and benefits

Taking part in this study won't directly improve your current health, as it's about understanding how treatments affect people generally. However, the information gathered could greatly help future children and young people with cancer by leading to safer and more personalised radiotherapy treatments. The main risk is the slight discomfort and small bruise that can sometimes happen when having a blood sample taken. There are no other risks related to your cancer treatment, as the study does not change your treatment plan. You are completely free to change your mind and leave the study at any time, without giving a reason, and this will not affect your medical care in any way.

Locations (2)

Centre François Baclesse
Verified postcode
Caen, France· Recruiting
Centre Oscar Lambret
Verified postcode
Lille, France· Not yet recruiting

Common questions

What is 'radiosensitivity'?

Radiosensitivity means how a person's body reacts or responds to radiation treatment.

Will this study change my cancer treatment?

No, taking part in this study will not change your planned cancer treatment in any way.

What will I have to do if I join?

The main thing you'll need to do is give a blood sample, usually during a regular hospital visit.

Will I get any extra medicine?

No, this study does not involve taking any new medicines or doing anything different from your usual care.

Can I stop taking part if I change my mind?

Yes, you can decide to leave the study at any time without giving a reason, and it won't affect your care.

How to find out more

Sandrine PEREIRA, PhD

spereira@neolys-diagnostics.fr 0643957510 Official trial record

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