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Molecular Biomarkers of Response to Radiation Therapy in Breast Cancer

I

Institute of Oncology Ljubljana

Status

Enrolling

Conditions

Radiotherapy Side Effect
Breast Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT06648148
DCIS-2019

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Any specific systemic oncological therapy

Trial contacts and locations

1

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Central trial contact

Tanja Marinko, MD, PhD

Data sourced from clinicaltrials.gov

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