Intensive Cancer Screening After Cryptogenic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: FDG PET/CT, Usual Care.
- Who it may be relevant to
- Registry conditions: Occult Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Intensive Cancer Screening After Cryptogenic Stroke (INCOGNITO) Pilot Randomized Trial
Overview
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 test FDG PET/CT
F-fluorodeoxyglucose positron emission/computed tomography - Diagnostic test Usual Care
Cancer screening according to sex, age and risk as per Canadian Task Force on Preventative Health Care
Primary outcome measures
- Participant Recruitment [Time frame: Over 12 months]
Secondary outcome measures (5)
- Eligibility Rate [Time frame: Over 12 months]
- Consent Rate [Time frame: Over 12 months]
- Retention Rate [Time frame: Over 24 months]
- Study Completion Rate [Time frame: Over 24 months]
- Adherence Rate [Time frame: Over 24 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Diagnostic
Study locations
Canada · 1 center
- The Ottawa Hospital — Ottawa
Identifiers
NCT: NCT05733416 · 20230006-01H