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

NCT06100718 | Recruiting

• 1 other identifier: 2021-01797
• Study Type: observational
• Target: 370
• Locations: 1 country
• Sites: 3

Brief Summary

INVISIBLE-1 aims to prospectively follow patients up to one year after ischemic stroke to:

1. 1.Determine the cumulative incidence of occult cancer in patients with embolic stroke of undetermined source (ESUS) and elevated D-dimer
2. 2.Describe occult cancer characteristics and spontaneous course of occult cancer

Conditions

Cancer-related Stroke; Paraneoplastic Coagulopathy; Occult Cancer; Ischemic Stroke; Embolic Stroke of Undetermined Source; D-dimer

Keywords

Cancer-related stroke; D-dimer; ESUS; Occult cancer; Ischemic stroke

Outcome Measures

Primary Outcomes (1)

• Number of participants with newly diagnosed cancer (occult cancer)

  Within 1 year after ischemic stroke

Secondary Outcomes (5)

• Determination of occult cancer characteristics

  Within 1 year after ischemic stroke

• Long-term functional outcome using the modified Rankin Scale (mRS) in stroke patients with occult cancer

  At 1 year after ischemic stroke

• All-cause mortality rate and cause-specific mortality rate

  At 1 year after ischemic stroke

• Rate of recurrent ischemic stroke, or systemic embolism in occult cancer-related stroke

  Within 1 year after ischemic stroke

• Stroke severity assessed with the National Institutes of Health Stroke Scale (NIHSS) score in patients with occult cancer

  Baseline

Study Arms (1)

Study group

Acute ischemic stroke patients at high-risk for underlying occult cancer (elevated D-dimer and suspicion of ESUS at admission)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (3)

Dept. of Neurology, Centre Hospital Universitaire Vaudois

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

Dept. of Neurology, Universitätsspital Basel

Basel, 4031, Switzerland

RECRUITING

Dept, of Neurology, Inselspital, University of Bern

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Simon Jung, MD

  Inselspital, University of Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Jung, MD

CONTACT

+41 31 63 2 43 27; simon.jung@insel.ch

Morin Beyeler, MD

CONTACT

+41 31 66 4 12 26; morin.beyeler@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 25, 2023
• Study Start: January 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 13, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (3)