Status:
RECRUITING
Discovery of New Cancer in the 1-year Follow-up After Ischemic Stroke in Patients at Risk: The INVISIBLE-1 Study
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Conditions:
Cancer-related Stroke
Paraneoplastic Coagulopathy
Eligibility:
All Genders
18+ years
Brief 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 sourc...
Detailed Description
INVISIBLE-1 is the first prospective study conducting a 1-year post-stroke follow-up telephone interview in preselected stroke patients at high-risk for occult cancer. INVISIBLE-1 aims to: 1. Prospe...
Eligibility Criteria
Inclusion
- 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
- 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 diagnosed within the previous six months, recurrent, regionally advanced or metastatic cancer, cancer for which treatment had been administered within six months, or hematological malignancy that is not in complete remission for more than 5 years.
- ► Patients with history of cancer not meeting these criteria anymore can be included in the study.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
370 Patients enrolled
Trial Details
Trial ID
NCT06100718
Start Date
January 1 2022
End Date
December 31 2025
Last Update
December 13 2024
Active Locations (3)
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1
Dept. of Neurology, Centre Hospital Universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland, 1011
2
Dept. of Neurology, Universitätsspital Basel
Basel, Switzerland, 4031
3
Dept, of Neurology, Inselspital, University of Bern
Bern, Switzerland, 3010