Molecular Biomarkers of Response to Radiation Therapy in Breast Cancer

NCT ID: NCT06648148

Last Updated: 2024-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-01

Study Completion Date

2029-12-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer Radiotherapy Side Effect

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Any specific systemic oncological therapy
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Ljubljana, Faculty of Medicine

OTHER

Sponsor Role collaborator

University Medical Centre Ljubljana

OTHER

Sponsor Role collaborator

Institute of Oncology Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tanja Marinko, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Oncology Ljubljana

Locations

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Institute of Oncology Ljubljana

Ljubljana, , Slovenia

Site Status RECRUITING

Countries

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Slovenia

Central Contacts

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Tanja Marinko, MD, PhD

Role: CONTACT

0038615879505

Facility Contacts

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Tanja Marinko, MD, PhD

Role: primary

0038615879505

Other Identifiers

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DCIS-2019

Identifier Type: -

Identifier Source: org_study_id

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