RecruitingNAINTERVENTIONAL

Predictive Toxicity Test Linked to Radiotherapy After Mastectomy and Immediate Implant Reconstruction

This study is investigating a new test called NovaGray RILA Breast®. It's designed for women who have breast cancer, need a mastectomy (breast removal surgery), and then have an immediate breast implant reconstruction. The aim is to see if this test can predict how likely they are to experience side effects from radiotherapy, which is often given after surgery. Radiotherapy can sometimes affect the look of the reconstructed breast and a woman's quality of life. By using this test, doctors hope to identify patients who might be at higher risk of these side effects before treatment even starts. This information could help them decide on the best treatment plan for each individual, potentially improving outcomes and satisfaction.

At a glance

Status

Recruiting

Phase

Sponsor

Institut du Cancer de Montpellier - Val d'Aurelle

Enrolment target

250

Start

11 Dec 2020

Estimated completion

10 Dec 2031

Breast Cancer Capsular Contracture Associated With Breast Implant

What is this study about?

When women have breast cancer and need their breast removed (a mastectomy), some choose to have a new breast built at the same time, which is called immediate implant reconstruction. This can help them cope with the surgery and avoid needing more operations later on. However, many women also need radiotherapy afterwards, which uses X-rays to kill any remaining cancer cells. While radiotherapy is very important, it can sometimes cause side effects that affect the reconstructed breast, changing its appearance or causing discomfort. This can then impact how a woman feels about her body and her overall wellbeing.

This study is looking at a special test called NovaGray RILA Breast®. This test works by looking at how certain cells in your body react, which can show how likely you are to experience side effects from radiotherapy. The main goal is to see if this test can accurately tell doctors which women are at a higher risk of developing these side effects after radiotherapy, especially when they have an immediate breast implant.

If this test works well, it could be a game-changer. Doctors could use this information even before treatment begins to make more personalised decisions about a woman's care. For example, if someone is identified as high-risk, doctors might adjust their treatment plan to try and reduce those side effects. Conversely, if someone is low-risk, it might mean they can avoid additional unnecessary procedures. Ultimately, the aim is to help doctors create the best possible treatment plan for each individual woman, improving both their physical results and their quality of life.

Key takeaways

A new test is being studied to predict radiotherapy side effects after breast reconstruction.
This could help doctors tailor treatment plans for women with breast cancer.
The study focuses on women who have mastectomies and immediate implant reconstruction.
It aims to improve patient care by identifying those at higher risk of side effects.
Participation involves a blood test and follow-up on your recovery.

Who may be eligible?

To be considered for this study, you would generally need to be an adult (18 years or older) and have been diagnosed with breast cancer. You must either be scheduled for a mastectomy (breast removal) or have already had one, and your doctors must recommend radiotherapy to your chest wall after surgery.

It's important that you have agreed to, or have already had, an immediate breast reconstruction using an implant. While many women are being considered for this study, those with certain types of breast cancer, such as inflammatory breast cancer or cancer that has already spread to other parts of the body, would not be suitable. Also, if you've had radiotherapy to the same breast previously, or if you're pregnant or breastfeeding, you wouldn't be able to join.

The study also needs you to be able to attend follow-up appointments and be part of the French national social security system. You also can't be taking part in another medical study that involves intervention.

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 old or older?
Do you have breast cancer and need, or have you had, a mastectomy?
Has your doctor recommended radiotherapy to your chest wall after surgery?
Have you agreed to, or have you already had, an immediate breast reconstruction with an implant?
Are you not currently pregnant or breastfeeding?
Are you able to attend follow-up appointments?

Answer every question to see your result.

What does participation involve?

This is a study that uses a special test. If you join, you would have the NovaGray RILA Breast® test, which involves a simple blood test. The researchers will then carefully follow you to see how your body reacts to radiotherapy and how your reconstructed breast heals over time. You will have regular check-ups, which might involve physical examinations and discussions about how you're feeling and the appearance of your breast. The study will track your progress after radiotherapy. The total duration of your involvement in the study will be determined by the follow-up period needed to assess the long-term effects of radiotherapy, but you may be followed for up to 12 months after radiotherapy.

Potential risks and benefits

Taking part in this study could help doctors better understand how to predict radiotherapy side effects for women having breast reconstruction, which might lead to better treatment planning in the future. As the test involves a blood sample, the main risks are those associated with a standard blood test, such as mild bruising or discomfort. There are no direct medical recommendations made within this study. Remember, your participation is completely voluntary, and you are free to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (9)

Centre Georges François Leclerc
Verified postcode
Dijon, France· Recruiting
Centre Oscar Lambret
Verified postcode
Lille, France· Recruiting
Centre Léon Bérard
Verified postcode
Lyon, France· Recruiting
Institut Paoli Calmette
Verified postcode
Marseille, France· Recruiting
Institut du Cancer de Montpellier
Verified postcode
Montpellier, France· Recruiting
centre Antoine Lacassagne
Verified postcode
Nice, France· Recruiting
Hôpital Tenon
Verified postcode
Paris, France· Recruiting
Institut de Cancérologie de l'Ouest
Verified postcode
Saint-Herblain, France· Recruiting
Institut Claudius Regaud
Verified postcode
Toulouse, France· Recruiting

Common questions

What is the NovaGray RILA Breast® test?

It's a new test that aims to predict how likely you are to experience side effects from radiotherapy, especially after breast implant reconstruction.

Why is this test important?

It could help doctors choose the best and most personalised treatment plan for each patient, potentially reducing unwanted side effects from radiotherapy.

Will I get personalised results from the test during the study?

The study aims to evaluate the test's ability to predict toxicity for future use, not necessarily to provide individual results for immediate treatment changes during THIS study.

Who is funding this study?

The information provided does not specify the funding source for this particular study.

If I join, will my treatment change?

This study is evaluating a test. Its purpose is to gather information, and it's not looking to make immediate changes to your current treatment based on the test results during the study.

How to find out more

Aurore MOUSSION

drci-icm105@icm.unicancer.fr 04 67 61 31 02 Official trial record

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