Active not recruitingNAINTERVENTIONAL

Predictive Role of New Biomarkers for Hypersensitive Patients to Radiation in Breast Cancer (BIORISE)

This study, called BIORISE, is for women with breast cancer. We are looking at proteins in blood samples to understand why some patients have a stronger reaction to radiotherapy than others. The goal is to develop a simple blood test that can predict if a patient might experience more side effects from radiation treatment. By identifying these patients early, doctors could tailor their treatment plans to reduce the risk of strong reactions. This research aims to confirm previous findings and validate a blood test based on five specific proteins. Ultimately, it could lead to more personalised and safer breast cancer care.

At a glance

Status

Active not recruiting

Phase

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrolment target

500

Start

01 Aug 2014

Breast Cancer

What is this study about?

When people have breast cancer, a common treatment is radiotherapy, which uses high-energy rays to kill cancer cells. While radiotherapy is very effective, some people might experience more side effects than others, even though they receive a similar treatment. This study is trying to understand why this happens.

Researchers are looking for specific proteins in the blood that might act as warning signs. Think of these proteins as tiny messengers in your body. By studying these messengers, scientists hope to find a way to predict which patients might have a stronger reaction to the radiation before their treatment even starts. This could allow doctors to adjust the treatment plan to make it safer and more comfortable for those individuals.

Specifically, this study will take a blood sample from women who are planning to have radiotherapy for breast cancer. They will then look at five particular proteins in these blood samples. The aim is to see if measuring these proteins can reliably tell doctors who might be more sensitive to radiation. If successful, this could lead to a new simple blood test that helps doctors give more personalised care, making treatment safer and more effective for each patient.

Key takeaways

The study aims to improve breast cancer radiotherapy.
It involves a single blood sample to look for specific proteins.
The goal is to develop a new test to predict radiotherapy reactions.
Participation will not change your current treatment plan.
Results could lead to more personalised and safer care for future patients.

Who may be eligible?

This study is looking for women who have breast cancer and are planning to have radiotherapy after surgery or chemotherapy. You might be suitable if your cancer is in the breast (either invasive or very early stage) and you don't have cancer spread to other parts of your body. If you've had chemotherapy, it needs to have finished at least one month before your radiotherapy starts.

There are some specific requirements. You need to be over 18 years old and able to provide a blood sample. You should also be able to understand the study information and agree to take part. It's important that you haven't received radiation treatment to the same area before, and you're not having a specific type of radiation called proton therapy.

You would not be able to join if your cancer has spread, if you're a male with breast cancer, or if you've had a mastectomy (full breast removal) or bilateral breast cancer. Patients who are pregnant, have limited life expectancy, or are unable to give informed consent due to mental disability also cannot participate. Additionally, if you have breast implants that won't be removed during surgery, you cannot join.

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 a woman with breast cancer?
Are you planning to have radiotherapy?
Are you over 18 years old?
Are you able to give a blood sample?
Do you understand the study and agree to participate?
Has your chemotherapy finished at least a month ago (if applicable)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it's quite straightforward. You will be asked to provide a single blood sample. This is like a routine blood test you might have at your doctor's surgery or hospital. The researchers will then analyse this blood sample for the specific proteins they are interested in. There are no extra visits or changes to your planned medical treatment. The study simply involves giving that blood sample before you start your radiotherapy. Your participation in the study itself does not involve any medication or follow-up beyond providing the blood sample.

Potential risks and benefits

Taking part in this study is generally considered low-risk, as it only involves providing a blood sample, similar to those taken for standard medical care. There's a small chance of bruising or discomfort from the needle. The main benefit is that your participation helps researchers learn more about how to predict individual responses to radiotherapy. This could lead to better, more personalised treatments for future breast cancer patients. You can choose to leave the study at any time without it affecting your medical care.

Locations (1)

Institut régional du Cancer de Montpellier
Verified postcode
Montpellier, France

Common questions

What is the main goal of this study?

The main goal is to find out if a simple blood test can predict which breast cancer patients might have a stronger reaction to radiotherapy.

Do I need to do anything special to participate?

No, you just need to provide one blood sample. It won't change your planned cancer treatment.

Will this study change my cancer treatment?

No, taking part in this study will not affect your breast cancer treatment plan.

What is meant by 'hypersensitive patients'?

This refers to patients who might experience stronger-than-usual side effects from radiotherapy.

Will I get my results from the blood test?

The study aims to develop a test for future use, so individual results from this research phase are generally not shared directly with participants.