Discovery of New Cancer in the 1-year Follow-up After Ischemic Stroke in Patients at Risk: The IN… (NCT06100718) | Clinical Trial Compass
RecruitingNot Applicable
Discovery of New Cancer in the 1-year Follow-up After Ischemic Stroke in Patients at Risk: The INVISIBLE-1 Study
Switzerland370 participantsStarted 2022-01-01
Plain-language summary
INVISIBLE-1 aims to prospectively follow patients up to one year after ischemic stroke to:
1. Determine the cumulative incidence of occult cancer in patients with embolic stroke of undetermined source (ESUS) and elevated D-dimer
2. Describe occult cancer characteristics and spontaneous course of occult cancer
Methodology
The investigators will include 370 stroke patients with elevated D-dimer (≥ 820 μg/L) at the time of stroke, suspicion of ESUS after initial workup and without known cancer. The investigators will perform a follow-up telephone interview at one year to assess the occurrence of a new cancer and characterize the course of the disease.
Significance
Determining the real incidence of occult cancer in high-risk patients will help support the implementation of screening trials in the future. Faster detection and treatment of occult cancers would significantly impact patient' outcomes by offering faster cancer treatment and optimal secondary stroke prevention.
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:
* Informed consent as documented by signature from patient or next of kin
* Age ≥ 18 years old
* Acute ischemic stroke with symptom onset within 48 h before admission
* Acute ischemic stroke with:
* persistent signs and symptoms of stroke lasting for ≥ 24 hours OR
* acute brain infarction documented by computer tomography (CT) or MRI
* D-dimer ≥ 820 μg/L measured after symptom-onset and within 24h after admission
* Embolic stroke of unknown source (ESUS)\* after initial work-up (acute cerebral imaging, 12-lead electrocardiogram, cardiac monitoring for at least 24h and echocardiography)
Exclusion Criteria:
* Active cancer\*\* known at time of index-stroke
* Intravenous Thrombolysis administrated prior to D-dimer measurement: Use of external laboratory value possible if available
* New diagnosis of central nervous system cancer
* Patient or next of kin (in case of lacking capacity) unlikely to be compliant or available for study follow-up interview
ESUS\*: According to the definition from the NAVIGATE ESUS randomized trial: Non-lacunar ischemic stroke occurring in a patient in whom investigations did not show another specifically treatable underlying stroke etiology, primarily \>50% stenosis in a proximal extracranial or intracranial artery, atrial fibrillation, other major-risk cardioembolic sources, or other determined etiology.
Active Cancer\*\*: According to the definition from the International Society on Thrombosis and Haemostasis: Cancer dia…
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
Number of participants with newly diagnosed cancer (occult cancer)