Intensive Cancer Screening After Cryptogenic Stroke
ConditionOccult Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOttawa Hospital Research Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
FDG PET/CT
Diagnostic testF-fluorodeoxyglucose positron emission/computed tomography
Usual Care
Diagnostic testCancer screening according to sex, age and risk as per Canadian Task Force on Preventative Health Care
Treatment groups
45 Participants
are divided into 2 treatment groupsGroup A: Intensive Cancer ScreeningExperimental treatment 1 intervention
Group B: Usual CareOther 1 intervention
Trial outcomes
Primary outcomes
1
Participant Recruitment
Number of participants recruited
Time frame
Over 12 monthsSecondary outcomes
1
Eligibility Rate
percentage of screened patients who are eligible
Time frame
Over 12 months2
Consent Rate
percentage of eligible patients who provide consent
Time frame
Over 12 months3
Retention Rate
percentage of participants retained at follow-up
Time frame
Over 24 months4
Study Completion Rate
percentage of participants who completed all study procedures
Time frame
Over 24 monthsOther outcomes
1
Screening time frame
time from diagnosis to screening
Time frame
Over 24 months2
Reasons for participation
Reasons for accepting/declining participation
Time frame
Over 24 months3
Usual care cancer screening strategies
Usual care cancer screening strategies ordered by treating physicians
Time frame
Over 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ottawa Hospital Research Institute
Lead sponsor
Brain Canada
Collaborator
Heart and Stroke Foundation of Canada
Collaborator
Canadian Stroke Consortium (CSC)
Collaborator
Source ClinicalTrials.gov