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Intensive Cancer Screening After Cryptogenic Stroke (INCOGNITO)

Primary Purpose

Occult Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
FDG PET/CT
Usual Care
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Occult Cancer focused on measuring cryptogenic stroke

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Other

    Arm Label

    Intensive Cancer Screening

    Usual Care

    Arm Description

    Usual care plus PDG PET/CT

    Cancer screening according to sex, age and risk as per Canadian Task Force on Preventative Health Care)

    Outcomes

    Primary Outcome Measures

    Participant Recruitment
    Number of participants recruited

    Secondary Outcome Measures

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

    Full Information

    First Posted
    January 28, 2023
    Last Updated
    March 28, 2023
    Sponsor
    Ottawa Hospital Research Institute
    Collaborators
    Brain Canada, Heart and Stroke Foundation of Canada, Canadian Stroke Consortium (CSC)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05733416
    Brief Title
    Intensive Cancer Screening After Cryptogenic Stroke
    Acronym
    INCOGNITO
    Official Title
    Intensive Cancer Screening After Cryptogenic Stroke (INCOGNITO) Pilot Randomized Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2023 (Anticipated)
    Primary Completion Date
    January 2024 (Anticipated)
    Study Completion Date
    January 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ottawa Hospital Research Institute
    Collaborators
    Brain Canada, Heart and Stroke Foundation of Canada, Canadian Stroke Consortium (CSC)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Occult Cancer
    Keywords
    cryptogenic stroke

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intensive Cancer Screening
    Arm Type
    Experimental
    Arm Description
    Usual care plus PDG PET/CT
    Arm Title
    Usual Care
    Arm Type
    Other
    Arm Description
    Cancer screening according to sex, age and risk as per Canadian Task Force on Preventative Health Care)
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    FDG PET/CT
    Intervention Description
    F-fluorodeoxyglucose positron emission/computed tomography
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Usual Care
    Intervention Description
    Cancer screening according to sex, age and risk as per Canadian Task Force on Preventative Health Care
    Primary Outcome Measure Information:
    Title
    Participant Recruitment
    Description
    Number of participants recruited
    Time Frame
    Over 12 months
    Secondary Outcome Measure Information:
    Title
    Eligibility Rate
    Description
    proportion of screened patients who are eligible
    Time Frame
    Over 12 months
    Title
    Consent Rate
    Description
    proportion of eligible patients who provide consent
    Time Frame
    Over 12 months
    Title
    Retention Rate
    Description
    proportion of participants retained at follow-up
    Time Frame
    Over 24 months
    Title
    Study Completion Rate
    Description
    proportion of participants who completed all study procedures
    Time Frame
    Over 24 months
    Title
    Adherence Rate
    Description
    adherence to screening strategy
    Time Frame
    Over 24 months
    Other Pre-specified Outcome Measures:
    Title
    Screening time frame
    Description
    time from diagnosis to screening
    Time Frame
    Over 24 months
    Title
    Reasons for participation
    Description
    Reasons for accepting/declining participation
    Time Frame
    Over 24 months
    Title
    Usual care cancer screening strategies
    Description
    Usual care cancer screening strategies ordered by treating physicians
    Time Frame
    Over 24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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)

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Intensive Cancer Screening After Cryptogenic Stroke

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