Molecular Biomarkers of Response to Radiation Therapy in Breast Cancer

Recruiting

• Conditions: Breast Cancer; Radiotherapy Side Effect

• Registration Number: NCT06648148
• Lead Sponsor: Institute of Oncology Ljubljana

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.

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2023-01-30
• Status Verified: 2024-10
• Study First Submitted QC: 2024-10-16
• Last Update Submitted: 2024-10-16
• Study First Posted: 2024-10-18
• Last Update Posted: 2024-10-18
• Primary Completion: 2026-12-31
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Breast cancer patients with DCIS with an indication for adjuvant radiation therapy

Exclusion Criteria

• Any specific systemic oncological therapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse events of radiation therapy	5 years after 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 Outcome Measures

Name	Time	Method
Disease recurrence	10 years after radiotherapy	We will assess the proportion of patients with disease recurrence.
Changes of circulating biomarkers	5 years after radiotherapy	We will assess the changes of circulating biomarkers (miRNA, extracellular vesicles, proteins) after radiotherapy compared to values before radiotherapy.

Trial Locations

Locations (1)

Institute of Oncology Ljubljana; 🇸🇮 Ljubljana, Slovenia