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| Name | Class |
|---|---|
| French Nuclear Safety and Radiation Protection Authority (ASNR) | OTHER_GOV |
| Institut Claudius Regaud | OTHER |
| University Hospital, Toulouse | OTHER |
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The purpose of this study is to determine whether a new technique of radiotherapy for breast cancer (helical tomotherapy) can induce cardiac toxicity that would be detected in the first two years after treatment. Screening of subclinical cardiac lesions with non-invasive cardiac imaging techniques combined with measures of circulating biomarkers of cardiac tissue lesions and coronary lesions would allow assessing radiation-induced cardiac toxicity at an early stage.
REBECCA study will consist in a monocentric prospective cohort that will include 120 women volunteers treated with adjuvant tomotherapy for breast cancer in the Institut Regaud Claudius-Toulouse (ICR) and followed for 2 years after radiotherapy.
In summary, women aged between 40 and 70 years, surgically treated at ICR for breast cancer and for whom adjuvant radiotherapy with tomotherapy is indicated, with no indication of chemotherapy will be eligible for the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Helical tomotherapy for breast cancer | Other | All women included in REBECCA cohort will be treated with helical tomotherapy for theur breast cancer. Their cardiac follow-up will be based on echocardiography, CT coronary angiogram and blood samples |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Helical tomotherapy for breast cancer | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with subclinical cardiac lesions in myocardial levels and/or coronary levels | The primary outcome is defined as a decrease of at least 5% in strain or strain rate measures based on cardiac ultrasound exam"2D strain" between the measurement before radiotherapy and measures 24 months after radiotherapy and / or an increase of at least 15% in the average index of coronary plaques measured with CT coronary angiogram between the measurement before radiotherapy and measures 24 months after radiotherapy . | within the first 2 years after tomotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with decrease in myocardial contractility (strain or strain rate measured with cardiac ultrasound exam"2D strain") | within the first 6 months after tomotherapy | |
| Number of participants with modified measures of circulating biomarkers |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carole Massabeau, MD | Institut Claudius Regaud, Toulouse (France) | Principal Investigator |
| Marie-Odile Bernier, MD | Institut de Radioprotection et de Sureté Nucléaire, Fontenay-aux-Roses (France) | Principal Investigator |
| Jean Ferrières, MD, PhD | University Hospital Rangueil, Toulouse (France) | Principal Investigator |
| Hervé Rousseau, MD, PhD | University Hospital Rangueil, Toulouse (France) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Claudius Regaud | Toulouse | 31000 | France |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Institut National de la Santé Et de la Recherche Médicale, France |
| OTHER_GOV |
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|
| within the first 2 years after tomotherapy (at the end of radiotherapy, 6 months after radiotherapy and 24 months maximum after radiotherapy) |
| D017437 |
| Skin and Connective Tissue Diseases |