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| Name | Class |
|---|---|
| University of Ljubljana, Faculty of Medicine | OTHER |
| University Medical Centre Ljubljana | OTHER |
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The purpose of this study is to identify potential genetic and other molecular biomarkers of response to radiation therapy in breast cancer that may help to personalize breast cancer radiation treatment in the future.
Monocentric prospective clinical study including DCIS patients treated at the Institute of Oncology Ljubljana. Patients treated with adjuvant radiotherapy and without systemic therapy are eligible for the study.
Adverse events of radiation treatment will be assessed after radiotherapy and during 5-year follow up and classified according to Common Terminology Criteria for Adverse Events v5.0.
Molecular biomarkers will be assessed before radiotherapy, after radiotherapy and during follow up. DNA will be isolated from whole blood samples obtained before radiation treatment. Circulating biomarkers will be isolated from plasma samples before treatment, after treatment and during follow-up. Written informed consent will be obtained from all included patients and the study design was approved by the National Medical Ethics Committee.
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| Measure | Description | Time Frame |
|---|---|---|
| Adverse events of radiation therapy | We will assess the proportion of patients exhibiting skin and cardiac adverse events after radiotherapy using Common Terminology Criteria for Adverse Events, NYHA class, measurement of cardiac biomarkers and cardiac imaging | Within 1 month after completion of radiotherapy |
| Adverse events of radiation therapy | We will assess the proportion of patients exhibiting skin and cardiac adverse events after radiotherapy using Common Terminology Criteria for Adverse Events, NYHA class, measurement of cardiac biomarkers and cardiac imaging | 6 months after radiotherapy |
| Adverse events of radiation therapy | We will assess the proportion of patients exhibiting skin and cardiac adverse events after radiotherapy using Common Terminology Criteria for Adverse Events, NYHA class, measurement of cardiac biomarkers and cardiac imaging | 2 years after radiotherapy |
| Adverse events of radiation therapy | We will assess the proportion of patients exhibiting skin and cardiac adverse events after radiotherapy using Common Terminology Criteria for Adverse Events, NYHA class, measurement of cardiac biomarkers and cardiac imaging | 5 years after radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Disease recurrence | We will assess the proportion of patients with disease recurrence. | 5 years after radiotherapy |
| Disease recurrence | We will assess the proportion of patients with disease recurrence. |
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Inclusion Criteria:
Exclusion Criteria:
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Breast cancer patients with non invasive ductal carcinoma in situ (DCIS) with an indication for postoperative radiation treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tanja Marinko, MD, PhD | Contact | 0038615879505 | tmarinko@onko-i.si |
| Name | Affiliation | Role |
|---|---|---|
| Tanja Marinko, MD, PhD | Institute of Oncology Ljubljana | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Oncology Ljubljana | Recruiting | Ljubljana | 1000 | Slovenia |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| 10 years after radiotherapy |
| Changes of circulating biomarkers | We will assess the changes of circulating biomarkers (miRNA, extracellular vesicles, proteins) after radiotherapy compared to values before radiotherapy. | Within 1 month after completion of radiotherapy |
| Changes of circulating biomarkers | We will assess the changes of circulating biomarkers (miRNA, extracellular vesicles, proteins) after radiotherapy compared to values before radiotherapy. | 6 months after radiotherapy, |
| Changes of circulating biomarkers | We will assess the changes of circulating biomarkers (miRNA, extracellular vesicles, proteins) after radiotherapy compared to values before radiotherapy. | 2 years after radiotherapy |
| Changes of circulating biomarkers | We will assess the changes of circulating biomarkers (miRNA, extracellular vesicles, proteins) after radiotherapy compared to values before radiotherapy. | 5 years after radiotherapy |
| D017437 |
| Skin and Connective Tissue Diseases |
| D014947 | Wounds and Injuries |