An observational study in Cancer-related Stroke, Paraneoplastic Coagulopathy and Occult Cancer, sponsored by Insel Gruppe AG, University Hospital Bern. Recruiting at 3 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-13.
Sponsored by Insel Gruppe AG, University Hospital Bern · Observational
INVISIBLE-1 aims to prospectively follow patients up to one year after ischemic stroke to:
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.
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:
Hypothesis
Elevated D-dimer and suspicion of ESUS at admission may predict an underlying unknown cancer at the time of index stroke. The investigators hypothesize that the cumulative incidence of newly diagnosed cancer within 1 year after stroke reaches 15% in patients presenting these characteristics. This percentage is higher than the 10% currently known according to available retrospective studies.
Project design
To ensure the recruitment of the majority of potential occult cancer patients, the investigators set the D-dimer cut-off for inclusion of ≥ 820 μg/L at admission, based on our intern retrospective analyses of 1001 patients (OCCULT-5 score). In patients with ESUS, this cut-off was associated with a sensitivity of 91% and a specificity of 56% for the presence of an occult cancer diagnosed within 1 year after the index-stroke.
As suggested by the current evidence, the investigators decided to set the limit for diagnosis of new cancer at 1 year after the index stroke. Beyond this period, the causality is questionable in our opinion.
This study aims to include 370 stroke-patients with elevated D-dimer (≥ 820 μg/L) at baseline and suspicion of ESUS after initial workup in emergency room.
Acute ischemic stroke with:
Exclusion Criteria:
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.
Acute ischemic stroke patients at high-risk for underlying occult cancer (elevated D-dimer and suspicion of ESUS at admission)
Number of participants with newly diagnosed cancer (occult cancer)
Time frame: Within 1 year after ischemic stroke
Determination of occult cancer characteristics
The description of the specific characteristics of occult cancers is defined by the location of the cancer, the histological type of cancer, the date of suspicion of cancer (e.g. via imaging), the type of investigation leading to the suspicion of cancer, the date of final diagnosis via histology, the presence of metastases at diagnosis, the type of treatment provided and the date of start of treatment.
Time frame: Within 1 year after ischemic stroke
Long-term functional outcome using the modified Rankin Scale (mRS) in stroke patients with occult cancer
The mRS (ranging from 0-6) measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. The higher the mRS score, the more disabled or dependent the patient (mRS 6 represents death).
Time frame: At 1 year after ischemic stroke
All-cause mortality rate and cause-specific mortality rate
Time frame: At 1 year after ischemic stroke
Rate of recurrent ischemic stroke, or systemic embolism in occult cancer-related stroke
Time frame: Within 1 year after ischemic stroke
Stroke severity assessed with the National Institutes of Health Stroke Scale (NIHSS) score in patients with occult cancer
NIHSS score is used to quantify stroke severity. It ranges from 0 to a maximum of 42 points. The higher the score, the more extensive the stroke.
Time frame: Baseline
Plan to share: No
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Insel Gruppe AG, University Hospital Bern