Occult Cancer
Conditions
Keywords
cryptogenic stroke
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.
Interventions
DIAGNOSTIC_TESTFDG PET/CT
F-fluorodeoxyglucose positron emission/computed tomography
DIAGNOSTIC_TESTUsual Care
Cancer screening according to sex, age and risk as per Canadian Task Force on Preventative Health Care
Sponsors
Brain Canada
Heart and Stroke Foundation of Canada
Canadian Stroke Consortium (CSC)
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Recruitment | Over 12 months | Number of participants recruited |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Consent Rate | Over 12 months | percentage of eligible patients who provide consent |
| Retention Rate | Over 24 months | percentage of participants retained at follow-up |
| Study Completion Rate | Over 24 months | percentage of participants who completed all study procedures |
| Adherence Rate | Over 24 months | adherence to screening strategy |
| Eligibility Rate | Over 12 months | percentage of screened patients who are eligible |
Other
| Measure | Time frame | Description |
|---|---|---|
| Usual care cancer screening strategies | Over 24 months | Usual care cancer screening strategies ordered by treating physicians |
| Reasons for participation | Over 24 months | Reasons for accepting/declining participation |
| Screening time frame | Over 24 months | time from diagnosis to screening |
Countries
Canada
Contacts
Primary ContactDariush Dowlatshahi, MD PhD
Backup ContactDeborah Siegal, MD
Outcome results
None listed