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NCT Number: NCT06648148

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.

Recruiting

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Radiation Injuries Radiotherapy Side Effect Skin Diseases Skin and Connective Tissue Diseases Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location status: Recruiting

Location contact

Tanja Marinko, MD, PhD

CONTACT

[email protected]

0038615879505

Tanja Marinko, MD, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Any specific systemic oncological therapy

Treatment and study plan

Primary outcomes

  1. Adverse events of radiation therapy

    Time frame: 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

  2. Adverse events of radiation therapy

    Time frame: 6 months 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

  3. Adverse events of radiation therapy

    Time frame: 2 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

  4. Adverse events of radiation therapy

    Time frame: 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 outcomes

  1. Disease recurrence

    Time frame: 5 years after radiotherapy

    We will assess the proportion of patients with disease recurrence.

  2. Disease recurrence

    Time frame: 10 years after radiotherapy

    We will assess the proportion of patients with disease recurrence.

  3. Changes of circulating biomarkers

    Time frame: 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.

  4. Changes of circulating biomarkers

    Time frame: 6 months after radiotherapy,

    We will assess the changes of circulating biomarkers (miRNA, extracellular vesicles, proteins) after radiotherapy compared to values before radiotherapy.

  5. Changes of circulating biomarkers

    Time frame: 2 years after radiotherapy

    We will assess the changes of circulating biomarkers (miRNA, extracellular vesicles, proteins) after radiotherapy compared to values before radiotherapy.

  6. Changes of circulating biomarkers

    Time frame: 5 years after radiotherapy

    We will assess the changes of circulating biomarkers (miRNA, extracellular vesicles, proteins) after radiotherapy compared to values before radiotherapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Tanja Marinko, MD, PhD

CONTACT

[email protected]

0038615879505

Sponsors and collaborators

Lead sponsor

Institute of Oncology Ljubljana

Other

Collaborators

  • University Medical Centre Ljubljana
  • University of Ljubljana, Faculty of Medicine

Registry information

Important dates

Study start
2019
Primary completion
2026
Study completion
2029
First posted
Oct 18, 2024
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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