Intensive Cancer Screening After Cryptogenic Stroke

Not Applicable

Recruiting

• Conditions: Occult Cancer
• Interventions: Diagnostic Test: Usual Care; Diagnostic Test: FDG PET/CT

• Registration Number: NCT05733416
• Lead Sponsor: Ottawa Hospital Research Institute

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-28
• Study First Submitted QC: 2023-02-08
• Study First Posted: 2023-02-17
• Study Start: 2023-09-01
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-30
• Last Update Posted: 2023-11-01
• Primary Completion: 2025-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 45

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	Cancer screening according to sex, age and risk as per Canadian Task Force on Preventative Health Care)
Intensive Cancer Screening	FDG PET/CT	Usual care plus PDG PET/CT

Primary Outcome Measures

Name	Time	Method
Participant Recruitment	Over 12 months	Number of participants recruited

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada