Intensive Cancer Screening After Cryptogenic Stroke

Study Overview
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Brief Summary
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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 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.

Official Title
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Intensive Cancer Screening After Cryptogenic Stroke (INCOGNITO) Pilot Randomized Trial

Conditions
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Occult Cancer

Intervention / Treatment
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* Diagnostic Test: FDG PET/CT
* Diagnostic Test: Usual Care


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive Cancer Screening<br>Usual care plus PDG PET/CT | Diagnostic Test: FDG PET/CT<br>* F-fluorodeoxyglucose positron emission/computed tomography<br>|
| Other: Usual Care<br>Cancer screening according to sex, age and risk as per Canadian Task Force on Preventative Health Care) | Diagnostic Test: Usual Care<br>* Cancer screening according to sex, age and risk as per Canadian Task Force on Preventative Health Care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Recruitment | Number of participants recruited | Over 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eligibility Rate | proportion of screened patients who are eligible | Over 12 months | 
| Consent Rate | proportion of eligible patients who provide consent | Over 12 months | 
| Retention Rate | proportion of participants retained at follow-up | Over 24 months | 
| Study Completion Rate | proportion of participants who completed all study procedures | Over 24 months | 
| Adherence Rate | adherence to screening strategy | Over 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cryptogenic stroke