Molecular Biomarkers of Response to Radiation Therapy in Breast Cancer

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Radiotherapy Side Effect

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 Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Tanja Marinko, MD, PhD; Phone Number: 0038615879505; Email: tmarinko@onko-i.si

Study Locations

• Slovenia
  • Ljubljana, Slovenia, 1000
    • Recruiting
    • Institute of Oncology Ljubljana
    • Contact: Tanja Marinko, MD, PhD; Phone Number: 0038615879505; Email: tmarinko@onko-i.si
    • Principal Investigator: Tanja Marinko, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Breast cancer patients with non invasive ductal carcinoma in situ (DCIS) with an indication for postoperative radiation treatment.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Any specific systemic oncological therapy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Institute of Oncology Ljubljana
• Collaborators: University Medical Centre Ljubljana; University of Ljubljana, Faculty of Medicine
• Investigators: Principal Investigator: Tanja Marinko, MD, PhD, Institute of Oncology Ljubljana

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: January 30, 2023
• First Submitted That Met QC Criteria: October 16, 2024
• First Posted (Actual): October 18, 2024

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: DCIS-2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No