Breast Cancer, Radiotherapy Side Effect
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
University of Ljubljana, Faculty of Medicine
University Medical Centre Ljubljana
Institute of Oncology Ljubljana
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Breast cancer patients with DCIS with an indication for adjuvant radiation therapy
Exclusion criteria
* Any specific systemic oncological therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events of radiation therapy | Within 1 month after completion of radiotherapy | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease recurrence | 5 years after radiotherapy | We will assess the proportion of patients with disease recurrence. |
| Changes of circulating biomarkers | Within 1 month after completion of radiotherapy | We will assess the changes of circulating biomarkers (miRNA, extracellular vesicles, proteins) after radiotherapy compared to values before radiotherapy. |
Countries
Slovenia
Contacts
Primary ContactTanja Marinko, MD, PhD
Outcome results
None listed