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

Studien-Informationen Einschlusskriterien Studien-Rationale

Rekrutierend

NCT-Nummer:
NCT06100718

Studienbeginn:
Januar 2022

Letztes Update:
25.10.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Stroke, Ischemic Stroke, Cerebral Infarction, Embolic Stroke, Ischemia

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Insel Gruppe AG, University Hospital Bern

Collaborator:
-

Kontakt

Simon Jung, MD
Kontakt:
Phone: +41 31 63 2 43 27
E-Mail: simon.jung@insel.ch» Kontaktdaten anzeigen

Morin Beyeler, MD
Kontakt:
Phone: +41 31 66 4 12 26
E-Mail: morin.beyeler@insel.ch» Kontaktdaten anzeigen

Studienlocations
(3 von 3)

Dept. of Neurology, Centre Hospital Universitaire Vaudois
1011 Lausanne
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Michel Patrik
Phone: +41 79 556 8416
E-Mail: patrik.michel@chuv.ch

Davide Strambo
Phone: +4121 314 17 74
E-Mail: Davide.Strambo@chuv.ch» Ansprechpartner anzeigen

Dept. of Neurology, Universitätsspital Basel
4031 Basel
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Mira Katan, MD
Phone: +41 61 328 45 06
E-Mail: Mira.Katan@usb.ch

Johannes Frenger
Phone: +41 61 265 25 25
E-Mail: Johannes.Frenger@usb.ch» Ansprechpartner anzeigen

Dept, of Neurology, Inselspital, University of Bern
3010 Bern
SwitzerlandRekrutierend» Google-Maps
Ansprechpartner:
Simon Jung, MD
Phone: +41 31 63 2 43 27
E-Mail: Simon.jung@insel.ch

Morin Beyeler, MD
Phone: +41 31 66 4 12 26
E-Mail: Morin.beyeler@insel.ch» Ansprechpartner anzeigen

Studien-Informationen

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. Prospectively determine the cumulative incidence of occult cancer in patients with

elevated D-dimer and ESUS within 1 year after the ischemic stroke

2. Describe occult cancer characteristics and spontaneous course of occult cancer

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.

Ein-/Ausschlusskriterien

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.

Studien-Rationale

Primary outcome:

1. Number of participants with newly diagnosed cancer (occult cancer) (Time Frame - Within 1 year after ischemic stroke)

Secondary outcome:

1. Determination of occult cancer characteristics (Time Frame - Within 1 year after ischemic stroke):
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.

2. Long-term functional outcome using the modified Rankin Scale (mRS) in stroke patients with occult cancer (Time Frame - At 1 year after ischemic stroke):
The mRS 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).

3. All-cause mortality rate and cause-specific mortality rate (Time Frame - At 1 year after ischemic stroke)

4. Rate of recurrent ischemic stroke, or systemic embolism in occult cancer-related stroke (Time Frame - Within 1 year after ischemic stroke)

5. Stroke severity assessed with the National Institutes of Health Stroke Scale (NIHSS) in patients with occult cancer (Time Frame - Baseline):
NIHSS 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.

Quelle: ClinicalTrials.gov

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