Identifying New Cancer After Ischemic Stroke in High-Risk Patients
Discovery of New Cancer in the 1-year Follow-up After Ischemic Stroke in Patients at Risk: The INVISIBLE-1 Study
This study is trying to see if people who had an ischemic stroke and have high D-dimer levels are more likely to be diagnosed with hidden cancer within a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 370 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 3 sites (Lausanne, Canton of Vaud and 2 other locations) |
| Trial ID | NCT06100718 on ClinicalTrials.gov |
What this trial studies
The INVISIBLE-1 study follows patients who have experienced an ischemic stroke and have elevated D-dimer levels to determine the incidence of occult cancer within one year. It includes 370 patients suspected of having an embolic stroke of undetermined source (ESUS) and assesses their cancer status through a follow-up telephone interview. The study aims to characterize the nature and progression of any newly diagnosed cancers, potentially leading to improved screening and treatment strategies for high-risk individuals.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have had an acute ischemic stroke with elevated D-dimer levels and no known cancer.
Not a fit: Patients with known active cancer or those who have received intravenous thrombolysis prior to D-dimer measurement will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection and treatment of occult cancers in stroke patients, improving their overall outcomes.
How similar studies have performed: While this study is novel in its prospective approach, previous retrospective studies have indicated a significant incidence of occult cancer in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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.
Where this trial is running
Lausanne, Canton of Vaud and 2 other locations
- Dept. of Neurology, Centre Hospital Universitaire Vaudois — Lausanne, Canton of Vaud, Switzerland (Recruiting)
- Dept. of Neurology, Universitätsspital Basel — Basel, Switzerland (Recruiting)
- Dept, of Neurology, Inselspital, University of Bern — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Simon Jung, MD — Inselspital, University of Bern
- Study coordinator: Simon Jung, MD
- Email: simon.jung@insel.ch
- Phone: +41 31 63 2 43 27
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.