NCT05927246

Brief Summary

Radiotherapy associated Atrial Fibrillation (RADAF) is an observational study to evaluate onset time and frequency of atrial fibrillation in patients with thoracic malignancies and breast cancer. Each patient will have 12 lead ECG prior, and daily during radiotherapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

January 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 3, 2023

Completed
Last Updated

July 3, 2023

Status Verified

June 1, 2023

Enrollment Period

5 months

First QC Date

June 23, 2023

Last Update Submit

June 29, 2023

Conditions

Keywords

Atrial fibrillationbreast cancerlung cancerthoracic malignanciescardiotoxicity

Outcome Measures

Primary Outcomes (2)

  • Occurrence of atrial fibrillation

    Occurrence of atrial fibrillation

    1 day During radiotherapy

  • Onset time of atrial fibrillation

    Onset time of atrial fibrillation

    1 day During radiotherapy

Study Arms (2)

Patients with Thoracic Malignancies

All patients undergoing RT for Thoracic Malignancies

Diagnostic Test: ECG

Patients with Breast Cancer

All patients undergoing RT for Breast Cancer

Diagnostic Test: ECG

Interventions

ECGDIAGNOSTIC_TEST

12 lead ecg for each participant

Patients with Breast CancerPatients with Thoracic Malignancies

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with breast and thoracic cancers will be evaluated for incidence and onset time of AFib.

You may qualify if:

  • Patients with radiotherapy for thoracic malignancy or breast cancer
  • Between 18-99 years-old

You may not qualify if:

  • Patients with history of radiotherapy
  • Patients with history of atrial fibrillation
  • Patients with pacemaker implantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Faculty of Medicine

Fatih, Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Atrial FibrillationBreast NeoplasmsLung NeoplasmsCardiotoxicity

Interventions

Electrocardiography

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Cafer Zorkun, MD PhD

    Faculty member

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Division of CardioOncology

Study Record Dates

First Submitted

June 23, 2023

First Posted

July 3, 2023

Study Start

January 1, 2023

Primary Completion

June 1, 2023

Study Completion

June 1, 2023

Last Updated

July 3, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations