Atrial Fibrillation in Active Cancer Patients (NCT04696081) | Clinical Trial Compass
RecruitingNot Applicable
Atrial Fibrillation in Active Cancer Patients
France1,000 participantsStarted 2021-09-01
Plain-language summary
Atrial fibrillation is a common complication of both cancer and anticancer drugs but the consequences of such events remain poorly known and are not adressed in both phase III oncological trials and cardiological guidelines. The objective of this study is to create a prospective multicenter international registry of adult patients with an active cancer and experiencing atrial fibrillation to study major cardiovascular events occurrence during a 1 year follow-up.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* adult patients
* outpatients or hospitalized patients
* with a confirmed cancer (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor, known intracerebral metastases, or acute leukemia) and an active cancer (defined as cancer that had been diagnosed within the past 6 months or recurrent locally advanced or metastatic cancer, for which anticancer treatment was being given at the time of enrollment or during 6 months before enrollment)
* at least 1 episode of atrial fibrillation (new onset AF occuring after cancer diagnosis or history of paroxysmal of persistant AF prior to cancer diagnosis and an AF recurrence after cancer diagnosis)
* in sinus rhythm at the time of cancer diagnosis
Exclusion Criteria:
* patient with palliative cares or other conditions resulting in short term death (death expected in the month following atrial fibrillation occurrence)
* history of long-standing persistant or permanent AF prior to cancer diagnosis
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of major cardiovascular events and death of any cause at 1 year
Timeframe: from inclusion in the registry to 1 year of follow-up