Clinical trial · Observational
Discovery of New Cancer in the 1-year Follow-up After Ischemic Stroke in Patients at Risk: The INVISIBLE-1 Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer-related Stroke | — | UNRESOLVED | — |
| D-dimer | — | UNRESOLVED | — |
| Embolic Stroke of Undetermined Source | — | UNRESOLVED | — |
| Ischemic Stroke | — | UNRESOLVED | — |
| Occult Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Paraneoplastic Coagulopathy | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Study group
- description
- Acute ischemic stroke patients at high-risk for underlying occult cancer (elevated D-dimer and suspicion of ESUS at admission)
Primary outcomes (1)
- measure
- Number of participants with newly diagnosed cancer (occult cancer)
- timeFrame
- Within 1 year after ischemic stroke
Secondary outcomes (5)
- measure
- Determination of occult cancer characteristics
- timeFrame
- Within 1 year after ischemic stroke
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available