Identifying New Cancer After Ischemic Stroke in High-Risk Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Preventing another ischemic stroke with a smart bracelet and app

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.