Atrial Fibrillation New OnsetRADAFNCT05927246
Radiotherapy-Associated Atrial Fibrillation
An observational study of Atrial Fibrillation New Onset, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Atrial Fibrillation New Onset
- What is being tested?
- ECG
- How many people
- 400 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with breast and thoracic cancers will be evaluated for incidence and onset time of AFib.
Who may be able to join
- Patients with radiotherapy for thoracic malignancy or breast cancer
- Between 18-99 years-old
Who cannot join
- Patients with history of radiotherapy
- Patients with history of atrial fibrillation
- Patients with pacemaker implantation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Faculty of Medicine
Fatih, Istanbul, 34093
About this study
Official title: Radiotherapy-associated Atrial Fibrillation: Onset Time and Frequency
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.
Read the detailed description
Collected data will be truly anonymised and individuals will no longer identifiable, and than evaluated for occurrence of atrial fibrillation.
Inclusing Criteria:
- Patients with radiotherapy for thoracic malignancy or breast cancer
- Between 18-99 years-old
Exclusion Criteria:
- Patients with history of radiotherapy
- Patients with history of atrial fibrillation
- Patients with pacemaker implantation
- Conditions
- Atrial Fibrillation New Onset
- Being tested
- ECG
- Keywords
- Atrial fibrillation, breast cancer, lung cancer, thoracic malignancies, cardiotoxicity
- Medical subject headings
- Atrial Fibrillation, Breast Neoplasms, Lung Neoplasms, Cardiotoxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECGDiagnostic test
12 lead ecg for each participant
| Study group | Role | What they receive |
|---|---|---|
| Patients with Thoracic Malignancies | All patients undergoing RT for Thoracic Malignancies Receives: Diagnostic Test: ECG | |
| Patients with Breast Cancer | All patients undergoing RT for Breast Cancer Receives: Diagnostic Test: ECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of atrial fibrillation
Occurrence of atrial fibrillation
Measured: 1 day During radiotherapy
Onset time of atrial fibrillation
Onset time of atrial fibrillation
Measured: 1 day During radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Jan 2023
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation New OnsetStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cafer Zorkun, Istanbul University
- Investigators
- Cafer Zorkun, MD PhD, Principal investigator, Faculty member
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927246
- Sponsor's protocol ID
- COEXIST-1
- Acronym
- RADAF
- Status last verified
- Jun 2023
- First submitted
- 23 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiotherapy-associated Atrial Fibrillation: Onset Time and Frequency
- ClinicalTrials.gov ID
- NCT05927246
- Acronym / sponsor ID
- RADAF / COEXIST-1
- Conditions
- Atrial Fibrillation New Onset
- Keywords
- Atrial fibrillation, breast cancer, lung cancer, thoracic malignancies, cardiotoxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Collected data will be truly anonymised and individuals will no longer identifiable, and than evaluated for occurrence of atrial fibrillation.
Inclusing Criteria:
- Patients with radiotherapy for thoracic malignancy or breast cancer
- Between 18-99 years-old
Exclusion Criteria:
- Patients with history of radiotherapy
- Patients with history of atrial fibrillation
- Patients with pacemaker implantation
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Thoracic Malignancies | – | Diagnostic Test: ECGAll patients undergoing RT for Thoracic Malignancies |
| Patients with Breast Cancer | – | Diagnostic Test: ECGAll patients undergoing RT for Breast Cancer |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with breast and thoracic cancers will be evaluated for incidence and onset time of AFib.
Key inclusion criteria (2 listed)
- Patients with radiotherapy for thoracic malignancy or breast cancer
- Between 18-99 years-old
Key exclusion criteria (3 listed)
- Patients with history of radiotherapy
- Patients with history of atrial fibrillation
- Patients with pacemaker implantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECG12 lead ecg for each participant | Diagnostic test | Patients with Breast Cancer, Patients with Thoracic Malignancies |
Primary outcome
Occurrence of atrial fibrillation
Time frame: 1 day During radiotherapy
Occurrence of atrial fibrillation
Onset time of atrial fibrillation
Time frame: 1 day During radiotherapy
Onset time of atrial fibrillation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cafer Zorkun, MD PhD principal investigator
Faculty member
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation New Onset, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of atrial fibrillation (time frame: 1 day During radiotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.