Molecular Biomarkers of Response to Radiation Therapy in Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Radiotherapy Side Effect. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Slovenia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Adverse events of radiation therapy [Time frame: Within 1 month after completion of radiotherapy]
- Adverse events of radiation therapy [Time frame: 6 months after radiotherapy]
- Adverse events of radiation therapy [Time frame: 2 years after radiotherapy]
- Adverse events of radiation therapy [Time frame: 5 years after radiotherapy]
Secondary outcome measures (6)
- Disease recurrence [Time frame: 5 years after radiotherapy]
- Disease recurrence [Time frame: 10 years after radiotherapy]
- Changes of circulating biomarkers [Time frame: Within 1 month after completion of radiotherapy]
- Changes of circulating biomarkers [Time frame: 6 months after radiotherapy,]
- Changes of circulating biomarkers [Time frame: 2 years after radiotherapy]
- Changes of circulating biomarkers [Time frame: 5 years after radiotherapy]
Eligibility criteria
Inclusion criteria
- Breast cancer patients with DCIS with an indication for adjuvant radiation therapy
Exclusion criteria
- Any specific systemic oncological therapy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Slovenia · 1 center
- Institute of Oncology Ljubljana — Ljubljana
Identifiers
NCT: NCT06648148 · DCIS-2019