Clinical trial NCT06648148: Molecular Biomarkers of Response to Radiation Therapy in Breast Cancer
Official title: Molecular Biomarkers of Response to Radiation Therapy in Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Radiotherapy Side Effect
Lead sponsor: Institute of Oncology Ljubljana
Sponsor class: OTHER
Collaborators: name: University of Ljubljana, Faculty of Medicine
name: University Medical Centre Ljubljana
First posted: 2024-10-18
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast cancer patients with non invasive ductal carcinoma in situ (DCIS) with an indication for postoperative radiation treatment.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Any specific systemic oncological therapy

Primary outcomes:
measure: Adverse events of radiation therapy
timeFrame: Within 1 month after completion of radiotherapy
measure: Adverse events of radiation therapy
timeFrame: 6 months after radiotherapy
measure: Adverse events of radiation therapy
timeFrame: 2 years after radiotherapy
measure: Adverse events of radiation therapy
timeFrame: 5 years after radiotherapy
Secondary outcomes:
measure: Disease recurrence
timeFrame: 5 years after radiotherapy
measure: Disease recurrence
timeFrame: 10 years after radiotherapy
measure: Changes of circulating biomarkers
timeFrame: Within 1 month after completion of radiotherapy
measure: Changes of circulating biomarkers
timeFrame: 6 months after radiotherapy,
measure: Changes of circulating biomarkers
timeFrame: 2 years after radiotherapy
measure: Changes of circulating biomarkers
timeFrame: 5 years after radiotherapy
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Institute of Oncology Ljubljana
Study officials:
affiliation: Institute of Oncology Ljubljana
name: Tanja Marinko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: