Discovery of New Cancer in the 1-year Follow-up After Ischemic Stroke in Patients at Risk: The INVISIBLE-1 Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorInsel Gruppe AG, University Hospital Bern

About this trial

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.

Eligibility criteria

Qualifiers

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

persistent signs and symptoms of stroke lasting for ≥ 24 hours OR

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

370 Participants
are grouped into 1 trial group