NCT06648148

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started Nov 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress64%
Nov 2019Dec 2029

Study Start

First participant enrolled

November 1, 2019

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

January 30, 2023

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

October 18, 2024

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

7.2 years

First QC Date

January 30, 2023

Last Update Submit

October 16, 2024

Conditions

Breast CancerRadiotherapy Side Effect

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (6)

  • Disease recurrence

    5 years after radiotherapy

  • Disease recurrence

    10 years after radiotherapy

  • Changes of circulating biomarkers

    Within 1 month after completion of radiotherapy

  • Changes of circulating biomarkers

    6 months after radiotherapy,

  • Changes of circulating biomarkers

    2 years after radiotherapy

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Any specific systemic oncological therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsRadiation Injuries

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesWounds and Injuries

Study Officials

  • Tanja Marinko, MD, PhD

    Institute of Oncology Ljubljana

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tanja Marinko, MD, PhD

CONTACT

0038615879505tmarinko@onko-i.si

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2023

First Posted

October 18, 2024

Study Start

November 1, 2019

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2029

Last Updated

October 18, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

SL(1)