NCT06100718Recruiting
Discovery of New Cancer in the 1-year Follow-up After Ischemic Stroke in Patients at Risk: The INVISIBLE-1 Study
Source: ClinicalTrials.gov · Last updated 13 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 370 (estimated)
- First submitted
- 9 Oct 2023
- Start date
- 1 Jan 2022
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Diseases
- Stroke
- NCT number
- NCT06100718
What you commit to
- Study type: Observational
- Planned participants: 370
- From 1 Jan 2022 to the primary completion date, 31 Dec 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Active cancer\*\* known at time of index-stroke
- 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.
Lab values
- Intravenous Thrombolysis administrated prior to D-dimer measurement: Use of external laboratory value possible if available
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dept. of Neurology, Universitätsspital Basel Coordinator of this site? Confirm its status | Basel | Switzerland | Recruiting |
| Dept, of Neurology, Inselspital, University of Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Recruiting |
| Dept. of Neurology, Centre Hospital Universitaire Vaudois Coordinator of this site? Confirm its status | Lausanne | Switzerland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.