Intensive Cancer Screening After Cryptogenic Stroke
INCOGNITO
1 other identifier
interventional
45
1 country
1
Brief Summary
The INCOGNITO Pilot Trial is a single centre pilot prospective randomized open-label blinded endpoint (PROBE) trial to assess the feasibility of a full-scale randomized trial to determine whether an occult cancer screening strategy of FDG PET/CT (F-fluorodeoxyglucose positron emission/computed tomography) in addition to usual care increases the number of occult cancers diagnosed after screening compared to usual care cancer screening alone in patients with cryptogenic stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2023
CompletedFirst Posted
Study publicly available on registry
February 17, 2023
CompletedStudy Start
First participant enrolled
September 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
July 31, 2025
July 1, 2025
3.3 years
January 28, 2023
July 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Participant Recruitment
Number of participants recruited
Over 12 months
Secondary Outcomes (5)
Eligibility Rate
Over 12 months
Consent Rate
Over 12 months
Retention Rate
Over 24 months
Study Completion Rate
Over 24 months
Adherence Rate
Over 24 months
Other Outcomes (3)
Screening time frame
Over 24 months
Reasons for participation
Over 24 months
Usual care cancer screening strategies
Over 24 months
Study Arms (2)
Intensive Cancer Screening
EXPERIMENTALUsual care plus FDG PET/CT
Usual Care
OTHERCancer screening according to sex, age and risk as per Canadian Task Force on Preventative Health Care)
Interventions
F-fluorodeoxyglucose positron emission/computed tomography
Cancer screening according to sex, age and risk as per Canadian Task Force on Preventative Health Care
Eligibility Criteria
You may qualify if:
- adults ≥18 years
- presenting to the Ottawa Hospital Stroke Prevention Clinic or the Ottawa Hospital Neurovascular Unit with a first cryptogenic ischemic stroke after advanced evaluation as per American Heart Association guidelines and Saver approach (maximum 3 months after stroke)
- patient or delegate willing and able to provide informed consent.
You may not qualify if:
- contraindications to FDG PET/CT (pregnancy or unable to lie still in bed for 20 minutes)
- active cancer or previous cancer diagnosis (other than basal or squamous cell carcinoma of the skin)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ottawa Hospital Research Institutelead
- Brain Canadacollaborator
- Heart and Stroke Foundation of Canadacollaborator
- Canadian Stroke Consortium (CSC)collaborator
Study Sites (1)
The Ottawa Hospital
Ottawa, Ontario, K1Y 4E9, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dariush Dowlatshahi, MD PhD
Ottawa Hospital Research Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2023
First Posted
February 17, 2023
Study Start
September 1, 2023
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
July 31, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share