Actively Recruiting
Discovery of New Cancer in the 1-year Follow-up After Ischemic Stroke in Patients at Risk: The INVISIBLE-1 Study
Led by Insel Gruppe AG, University Hospital Bern · Updated on 2024-12-13
370
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients who have had an ischemic stroke with a suspected embolic stroke of undetermined source (ESUS) and elevated D-dimer levels to find out how often hidden cancers are diagnosed within one year after the stroke. This study aims to track the occurrence and characteristics of such occult cancers and understand their natural progression. The study is observational and follows patients prospectively to gather important data that may improve future cancer screening and stroke prevention. The study includes 370 patients with ischemic stroke, elevated D-dimer levels of 820 cg/L or higher, and suspicion of ESUS after initial tests, but without known cancer at the time of stroke. Participants will be followed for one year, with a telephone interview conducted at the end of this period to detect any new cancer diagnoses and to describe the course of the disease. No experimental treatments are given, as this is an observational follow-up. During the study, participants will undergo standard stroke evaluations including imaging and cardiac monitoring to confirm ESUS and elevated D-dimer levels at admission. Researchers will track the number of new cancer diagnoses within one year, cancer characteristics, stroke severity, mortality rates, and recurrence of stroke or embolism. The primary outcome is the number of participants diagnosed with new cancer within one year. The study aims to provide data that could help future screening and treatment approaches for stroke patients at risk of hidden cancer.
CONDITIONS
Brief Title
Discovery of New Cancer in the 1-year Follow-up After Ischemic Stroke in Patients at Risk: The INVISIBLE-1 Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide informed consent by patient or next of kin signature
- Age 18 years or older
- Acute ischemic stroke with symptoms starting within 48 hours before admission
- Stroke with persistent symptoms lasting 24 hours or more, or brain infarction confirmed by CT or MRI
- D-dimer level 820 micrograms per liter or higher measured within 24 hours after admission
- Embolic stroke of unknown source after initial tests including imaging, ECG, cardiac monitoring, and echocardiography
You will not qualify if you...
- Known active cancer at time of stroke
- Received intravenous thrombolysis before D-dimer measurement
- New diagnosis of central nervous system cancer
- Patient or next of kin unlikely to comply with or be available for follow-up interview
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - 1 year
Participants are followed up for 1 year after ischemic stroke with telephone interviews to identify newly diagnosed cancers and assess outcomes related to stroke and cancer.
Periodic telephone interviews during the year
Trial Site Locations
Total: 3 locations
1
Dept. of Neurology, Centre Hospital Universitaire Vaudois
Lausanne, Canton of Vaud, Switzerland, 1011
Actively Recruiting
2
Dept. of Neurology, Universitätsspital Basel
Basel, Switzerland, 4031
Actively Recruiting
3
Dept, of Neurology, Inselspital, University of Bern
Bern, Switzerland, 3010
Actively Recruiting
Research Team
S
Simon Jung, MD
M
Morin Beyeler, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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